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https://openregulatory.com/questions/udi-and-eudamed-requirements-for-legacy-mdd-devices-as-of-may-2023 monthly 0.6 https://openregulatory.com/questions/is-it-necessary-to-have-technical-documentation-ready-before-certifying-a-qms-under-mdr-for-a-class-iia-medical-device monthly 0.6 https://openregulatory.com/questions/is-iso-13485-certification-still-valid-if-the-medical-device-is-discontinued monthly 0.6 https://openregulatory.com/questions/which-qms-software-should-we-choose 2024-05-19T10:12:59+02:00 monthly 0.6 https://openregulatory.com/questions/is-udi-required-for-class-i-devices-under-mdr-before-may-2025 monthly 0.6 https://openregulatory.com/questions/do-we-need-ai-machine-learning-deep-learning-medical-device-consultants 2024-05-07T11:17:11+02:00 monthly 0.6 https://openregulatory.com/questions/is-reduced-time-to-triage-via-telemedicine-a-clinical-benefit-under-mdr monthly 0.6 https://openregulatory.com/questions/why-are-some-devices-and-udis-not-listed-on-eudamed-despite-manufacturer-registration monthly 0.6 https://openregulatory.com/questions/redo-software-system-tests-after-minor-change 2024-05-08T17:16:00+02:00 monthly 0.6 https://openregulatory.com/questions/how-should-change-control-be-applied-to-complementary-software-in-medical-device-projects monthly 0.6 https://openregulatory.com/questions/are-there-equivalent-classifications-to-fda-class-i-and-ii-viewers-under-eu-mdr monthly 0.6 https://openregulatory.com/questions/minimum-number-users-usability-test-iec-62366 2024-05-08T17:15:15+02:00 monthly 0.6 https://openregulatory.com/questions/is-ce-marking-required-for-internally-used-medical-software-provided-as-a-service monthly 0.6 https://openregulatory.com/questions/mdr-clinical-evaluation-clinical-development-plan 2024-05-07T11:16:16+02:00 monthly 0.6 https://openregulatory.com/questions/machine-learning-software-medical-device-update-model 2024-05-07T11:15:25+02:00 monthly 0.6 https://openregulatory.com/questions/how-to-comply-with-eu-207-2012-electronic-ifu-requirements-for-medical-device-apps monthly 0.6 https://openregulatory.com/videos/ai-generate-your-qms-technical-documentation-in-3-minutes https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/5z19h8a2ygbhj76xu61vtco879pa?response-content-disposition=inline%3B%20filename%3D%22youtube_video_kk8Rjmjr_oQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_kk8Rjmjr_oQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a53972da62f9d5bd0e9986a30f7b16c7296f944ee27c6c02c4bc6770af7f72b2 AI-Generate Your QMS + Technical Documentation in 3 Minutes Use AI to generate your medical device QMS and technical documentation in just 3 minutes. The software used in the video is OpenRegulatory Formwork, an eQMS software for lean, founder-led companies. It's available for free, too, check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=kk8Rjmjr_oQ 2026-01-20T14:19:40+01:00 https://openregulatory.com/videos/free-iso-19011-internal-auditor-training-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/jopewi5lqkwlnegawj13qt41d6a7?response-content-disposition=inline%3B%20filename%3D%22youtube_video_zxHxrxzYPGI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_zxHxrxzYPGI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=b4f39d9eb785b264ed499dd45750cf9926b93e21c8756784ec2fdd301d05485e Free ISO 19011 Internal Auditor Training (for Medical Devices) Other companies offer ISO 19011 Internal Auditor Training which costs thousands of Euros, ours is free - and now on YouTube! Your company has to conduct an internal audit as a requirement for its medical device certification. Train yourself to be the auditor. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ And if you'd like to get a (free!) certificate and confirmation that you've successfully completed with video-based training on YouTube, you can generate your own training certificate in Formwork, too - just hit the link above, create an account and navigate to the Courses section. https://www.youtube.com/watch?v=zxHxrxzYPGI 2026-01-03T17:01:35+01:00 https://openregulatory.com/videos/free-mdr-prrc-course-person-responsible-for-regulatory-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ap0900d56ijyyp58uh90kr0n0xus?response-content-disposition=inline%3B%20filename%3D%22youtube_video_-a3QlZAqPUI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_-a3QlZAqPUI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=d4a255d69bb3bd56c1f9012acdb0c5b295501d9010c23ce42c762c320c2e9ffa Free MDR PRRC Course (Person Responsible for Regulatory Compliance) Join us for our free MDR PRRC course - no need to spend thousands of Euros on paid courses by other consultants. Sören explains the importance of having a Person Responsible for Regulatory Compliance (PRRC) in your company, as required by the MDR. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ And if you'd like to get a (free!) certificate and confirmation that you've successfully completed with video-based training on YouTube, you can generate your own training certificate in Formwork, too - just hit the link above, create an account and navigate to the Courses section. https://www.youtube.com/watch?v=-a3QlZAqPUI 2026-01-02T16:00:00+01:00 https://openregulatory.com/videos/medizinprodukteberater-course-examples https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ckgnjhd41k1muqxggf06jw1r5k05?response-content-disposition=inline%3B%20filename%3D%22youtube_video_c8KL6K9LJAc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_c8KL6K9LJAc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=84f9794e7a091f1bcdd9f5ab84134fcd26d2afedcbf6c0d307b86851d5ba0211 Medizinprodukteberater Course: Examples This is a legal role specific only to Germany ("Medizinprodukteberater"). (Sorry for the video blurriness) People - Are These MDC? CEO pitching your startup to investors who have Medical Device - related questions and concerns Salesperson making sales to physicians Salesperson making sales to hospitals Employee training patients for using your app A new developer writing code Customer support agents What does the MDC need to do in these situations? Customer support: A user complains about a technical bug Service technician: A customer complains about a bug which affected patient data Businessperson: Investors raise concerns about the risks of a planned product Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ And if you'd like to get a (free!) certificate and confirmation that you've successfully completed with video-based training on YouTube, you can generate your own training certificate in Formwork, too - just hit the link above, create an account and navigate to the Courses section. https://www.youtube.com/watch?v=c8KL6K9LJAc 2026-01-01T15:00:57+01:00 https://openregulatory.com/videos/medizinprodukteberater-course-requirements-tasks-responsibilities https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/fxmitojh4um9sh4ftoy15jd1kh46?response-content-disposition=inline%3B%20filename%3D%22youtube_video_GFNSWNsonRI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_GFNSWNsonRI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=723d231f3474368e9c615e0ab939aac6e1be1fa35fdd491665aa955f96863c18 Medizinprodukteberater Course: Requirements, Tasks, Responsibilities Le's learn about Medical Device Consultants. No, those are not the regulatory consultants which you hire. Those are people inside your company who fulfill a certain definition of consulting "expert groups", e.g. physicians. This is a legal role specific only to Germany ("Medizinprodukteberater"). Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ And if you'd like to get a (free!) certificate and confirmation that you've successfully completed with video-based training on YouTube, you can generate your own training certificate in Formwork, too - just hit the link above, create an account and navigate to the Courses section. https://www.youtube.com/watch?v=GFNSWNsonRI 2025-12-31T16:00:40+01:00 https://openregulatory.com/videos/post-market-surveillance-the-periodic-safety-update-report-psur https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/7ol3xzjfj9o732npbasbczmqflqn?response-content-disposition=inline%3B%20filename%3D%22youtube_video_6GaBb99mx8o_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_6GaBb99mx8o_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4e8cd4a64761c4c19f902b7612f2eaabb3cb2d12b5e44de9e848e27fbdc40388 Post-Market Surveillance: The Periodic Safety Update Report (PSUR) No plan without a report. Depending on your risk class you create a PMS Report or a PSUR. The differences, structures and a helpful MDCG Guidance - all in one video. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=6GaBb99mx8o 2025-12-30T14:00:19+01:00 https://openregulatory.com/videos/medical-device-post-market-surveillance-the-plan https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/cjokeq5zc47qfryjx2oarpzulyr2?response-content-disposition=inline%3B%20filename%3D%22youtube_video_AjSxUxP3x7k_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_AjSxUxP3x7k_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5f4f5902a8c66322fa4838f6975654807eb0504b12739f20023b73697be1a51a Medical Device Post-Market Surveillance: The Plan Every good SOP needs a plan. The PMS plan defines how you evaluate feedback from the field and how to identify trends in your data. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=AjSxUxP3x7k 2025-12-29T14:00:22+01:00 https://openregulatory.com/videos/medical-device-post-market-surveillance-the-process https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ys9knopa5kxwu14pimccrap2t3xk?response-content-disposition=inline%3B%20filename%3D%22youtube_video_1xDN0kSkrfw_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_1xDN0kSkrfw_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=176d308d0ea01ac5d916587bfb4e2f53ae661dfc7595d23c522c617debbe5695 Medical Device Post-Market Surveillance: The Process Post-market surveillance is a continuous cycle. In this video you will get to know our PMS SOP and will learn how to cluster feedback. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=1xDN0kSkrfw 2025-12-28T14:00:08+01:00 https://openregulatory.com/videos/free-medical-device-post-market-surveillance-course-concepts https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/vt78z2e9sv5wolj7jpfwr1qdvdcc?response-content-disposition=inline%3B%20filename%3D%22youtube_video_liEtDzmNsbA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_liEtDzmNsbA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7af336ffe7403f29154b6456b9f49c3205375fd7694e41a0aa0b1d434f9d17cf Free Medical Device Post-Market Surveillance Course: Concepts In this video we will dive into the concept of post-market surveillance. We will see how the reactive and pro-active surveillance of field data update the risk-management and the clinical evaluation. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=liEtDzmNsbA 2025-12-27T14:01:35+01:00 https://openregulatory.com/videos/post-market-clinical-follow-up-the-report-medical-device-clinical-evaluation https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/tufxf23b1vu44hc91iwi6fy506cq?response-content-disposition=inline%3B%20filename%3D%22youtube_video_XNTF2R8MXaM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_XNTF2R8MXaM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=d3e249c2a0c75c037ccdda173cd0561c2d91d3d4a57a802336589d72c3a8e643 Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation) After making a plan you need to summarize your PMCF data in the CER. We will see how to do that and which choices you have. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=XNTF2R8MXaM 2025-12-26T12:01:05+01:00 https://openregulatory.com/videos/post-market-clinical-follow-up-concepts-and-plan https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/yagoql6jnb5qnm5atwvb0yvrdk4g?response-content-disposition=inline%3B%20filename%3D%22youtube_video_lQDN1GQYXto_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_lQDN1GQYXto_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=85ed6878330d918be742977f423eddc9226618bbdc4327871fae2ff64629d0bf Post-Market Clinical Follow-up: Concepts and Plan The PMCF activities update the Clinical Evaluation Report. You will see which methods you can use and how to document them. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=lQDN1GQYXto 2025-12-25T12:01:32+01:00 https://openregulatory.com/videos/clinical-evaluation-post-market-surveillance-pms-database-search https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/96h74gb1eg5hswqsh8jzu7qr9bx5?response-content-disposition=inline%3B%20filename%3D%22youtube_video_7uGHnLS57SE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_7uGHnLS57SE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=80502908d22c538a6ec394d122e59db1acc9ef839b1cf1c49a858ecf0f6f405b Clinical Evaluation: Post-Market Surveillance (PMS) Database Search Post-Market Surveillance (PMS) data is needed for the CER and in this video I will show you how to search the BfArm database and how to extract and assess the results. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=7uGHnLS57SE 2025-12-24T12:00:15+01:00 https://openregulatory.com/videos/literature-search-for-clinical-evaluation-of-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bi47353sna45jz6j9502eo5mag98?response-content-disposition=inline%3B%20filename%3D%22youtube_video_e5UZeTmz5Zs_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_e5UZeTmz5Zs_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=92120f1ba605fa7b1435f0d2750e20974b6b12026e5c9ce7aa33ce748cad31ab Literature Search For Clinical Evaluation of Medical Devices Learn everything you need to know about the concepts of literature search in PubMed and how to use Excel as a free literature management tool. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=e5UZeTmz5Zs 2025-12-23T12:01:27+01:00 https://openregulatory.com/videos/clinical-evaluation-the-clinical-evaluation-report-cer https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/8h4iofllfh0ej20osfjen27qwpwe?response-content-disposition=inline%3B%20filename%3D%22youtube_video_XA_ewWmw734_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_XA_ewWmw734_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e97613f17ad1c8ee314e201a59a87844b55443e8ef1327ff04f72f82d7001086 Clinical Evaluation: The Clinical Evaluation Report (CER) You need to document and demonstrate the clinical evidence for your software. In this video we will see how to fill out the Clinical Evaluation Report (CER) template. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=XA_ewWmw734 2025-12-22T12:00:58+01:00 https://openregulatory.com/videos/clinical-evaluation-understanding-the-phases-and-the-plan https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/j1y753bepv1g7yskkkgla4ammuja?response-content-disposition=inline%3B%20filename%3D%22youtube_video_G4aDKsRRDvI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_G4aDKsRRDvI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=fd129050fbdfd475b181dc02761b47fbd063a4bb88d1759e7079a8cc1d4f10ba Clinical Evaluation: Understanding the Phases and the Plan In the second video, we will dive into the phases of the clinical evaluation and I will explain the Clinical Evaluation Plan (CEP). Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=G4aDKsRRDvI 2025-12-21T12:00:23+01:00 https://openregulatory.com/videos/free-clinical-evaluation-course-part-1-understanding-the-process https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/wm571qipd1oczotxbe4am6iewnyh?response-content-disposition=inline%3B%20filename%3D%22youtube_video_mIT3pZ0elDI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_mIT3pZ0elDI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=8604d35b95ca7872c6cf1f0c0d998c28c0683f94e1dd5f31d376f59346d1de2c Free Clinical Evaluation Course, Part 1: Understanding the Process In the first video, we will learn the basic concepts of the clinical evaluation and have a walk through the template of the Clinical Evaluation Process. Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies: https://openregulatory.com/ https://www.youtube.com/watch?v=mIT3pZ0elDI 2025-12-20T12:01:29+01:00 https://openregulatory.com/videos/registering-your-udi-in-eudamed-medical-device-database https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/hckok5vvp00lbi9r0mppj51azvgl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_iQxmI2g5M2Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_iQxmI2g5M2Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f8506a6a7cdea76514208555b7c4adc967fa8c8b7a3800abe311c4702619d476 Registering Your UDI in EUDAMED (Medical Device Database) In this video, we'll show you how to add your UDI to the EUDAMED database and access your EUDAMED account. It seems a bit confusing at first, but don't worry, we'll guide you through it. https://www.youtube.com/watch?v=iQxmI2g5M2Q 2025-12-19T10:01:16+01:00 https://openregulatory.com/videos/creating-a-udi-pi-and-data-matrix-code-at-ifa https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ry6k5v0vyp8ridfl78voe5zch3al?response-content-disposition=inline%3B%20filename%3D%22youtube_video_zWepyvAaUwA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_zWepyvAaUwA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=3f491a90537720a66b3e6ab34d59a3300cb82ffd2c52f44ad886c238b0f3bbda Creating a UDI-PI and Data Matrix Code at IFA In this video, we'll explain the basics of UDI.DI and UDI-PI in medical devices. We'll also show you how the UDI-DI can be in the form of a PPN or an HPC, and the importance of the UDI-PI, which consists of variables like batch number and expiry date. https://www.youtube.com/watch?v=zWepyvAaUwA 2025-12-18T10:01:32+01:00 https://openregulatory.com/videos/generating-the-basic-udi-di-at-ifa https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/74qh11a1m5lm8wgn2s5fwjfff2g7?response-content-disposition=inline%3B%20filename%3D%22youtube_video_RFjqls6zN-Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_RFjqls6zN-Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7bfda5ca825854e6233ab7e584d0c79600afbadd662df90502958cc4a52d1a3b Generating the Basic UDI-DI at IFA Let's take a look at how to generate your Basic UDI-DI with IFA. https://www.youtube.com/watch?v=RFjqls6zN-Q 2025-12-17T10:00:46+01:00 https://openregulatory.com/videos/hack-udi-di-for-free-with-hpc-at-ifa-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/9bhkp7pci07z48nasvbsqbdaao5w?response-content-disposition=inline%3B%20filename%3D%22youtube_video_ihXNeP9WGlg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_ihXNeP9WGlg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f7c9759830c2b28338da2ea046f0d36d028c52313ba5ce10bf124506c8251a1a Hack: UDI-DI for Free with HPC at IFA (for Medical Devices) In this video, we'll show you a little hack that can save you some money when buying a number from IFA. https://www.youtube.com/watch?v=ihXNeP9WGlg 2025-12-16T10:01:10+01:00 https://openregulatory.com/videos/ifa-ordering-a-ppn-via-auftragstabelle-b3 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/frch2af6erp58k0p7v23xmbkvgfu?response-content-disposition=inline%3B%20filename%3D%22youtube_video_FyD-yjZGE5Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_FyD-yjZGE5Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5e0fd98220380dc88d344043e443302feab377a2571a87a034bfdaa4b5b1159e IFA: Ordering a PPN via Auftragstabelle B3 In this video, we'll guide you through the process of filling out the order form for your first pharmacy product number (PPN). This is very intuitive. https://www.youtube.com/watch?v=FyD-yjZGE5Q 2025-12-16T10:00:26+01:00 https://openregulatory.com/videos/registering-as-a-customer-at-ifa-to-create-a-udi https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/elqrs5uywk1n8doy6s307fwayot2?response-content-disposition=inline%3B%20filename%3D%22youtube_video_uJ5KXsEDQoI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_uJ5KXsEDQoI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=2fc500bb546ca4662fc05fcc1bc87d5c0ff7b6bf519352a66c1000e66391e713 Registering As a Customer at IFA to Create a UDI I will guide you through the process of obtaining your PPN (Product Provider Number) on the IFA website. I'll explain how the communication happens via email and what documents you need to send to receive your number. https://www.youtube.com/watch?v=uJ5KXsEDQoI 2025-12-15T10:01:22+01:00 https://openregulatory.com/videos/creating-a-medical-device-udi-at-ifa-unique-device-identifier https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/kj3f0z9dqej3bathbdn02hisrgdg?response-content-disposition=inline%3B%20filename%3D%22youtube_video_NsKhSpqD7II_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_NsKhSpqD7II_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=d35f38816a7a8237b8c3101528b59e2c6fbc73c4bf60655a577e25155f41d071 Creating a Medical Device UDI at IFA (Unique Device Identifier) IFA is another UDI provider besides GS1. While you only have select one (no need to bother with both!), we've still gone through the process of getting a UDI with IFA, too, so you can pick and choose whatever provider you prefer. https://www.youtube.com/watch?v=NsKhSpqD7II 2025-12-12T10:00:47+01:00 https://openregulatory.com/videos/udi-pi-and-barcode-with-application-identifiers-in-gs1 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/cg9tpym10tca58vhtraxrqlfayql?response-content-disposition=inline%3B%20filename%3D%22youtube_video_meW5KekyPIg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_meW5KekyPIg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e9afd7d3680742a208902380d3f64235f1a4774e8c24c07dd9894300e6c5698a UDI-PI and Barcode With Application Identifiers in GS1 In this video, we'll guide you through the process of creating a Unique Device Identifier Product Identifier (UDI PI) and generating barcodes for product identification with GS1. https://www.youtube.com/watch?v=meW5KekyPIg 2025-12-11T10:01:20+01:00 https://openregulatory.com/videos/creating-the-basic-udi-di-as-gmn-in-gs1 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/y6oru51gw6f47ej3wb5ahecadutp?response-content-disposition=inline%3B%20filename%3D%22youtube_video_qaJh72SABt0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_qaJh72SABt0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7818f9251f5c58857c02890ec0b0139bd648c9f3bd685119a47b862fa250f72e Creating the Basic UDI-DI as GMN in GS1 In this video, we'll guide you through the process of creating a basic UDI-DI using the very user-friendly GS1 system. https://www.youtube.com/watch?v=qaJh72SABt0 2025-12-10T10:01:32+01:00 https://openregulatory.com/videos/how-to-use-the-gs1-gtin-manager-udis-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/xqqz7ii58j1yummxsmnxkedc6nf6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Q1h8ydDHhb0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Q1h8ydDHhb0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=97f5e776b0f900eb29ebd8357ea75045f3fcbcd72417948e6fcc7faaaf77a9a3 How to Use The GS1 GTIN Manager (UDIs for Medical Devices) Let's take a look at how to create a new device at GS1, which is the prerequisite for getting our UDI. For that, we have to use the intuitive GTIN manager at GS1, a UDI provider. https://www.youtube.com/watch?v=Q1h8ydDHhb0 2025-12-09T10:00:44+01:00 https://openregulatory.com/videos/registering-a-udi-with-gs1-unique-device-identifiers-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/nwaxwazyf9x7uscqqntth18u4ait?response-content-disposition=inline%3B%20filename%3D%22youtube_video_CH8cyMeZWhk_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_CH8cyMeZWhk_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f4e52b1c70f1e59e6f6573a507e9a1930ec6e724ee83f73dcb5f99150b8e27e0 Registering a UDI with GS1 (Unique Device Identifiers for Medical Devices) Let's register at GS1, a company with a totally non-shady pricing model, and purchase our first UDI! https://www.youtube.com/watch?v=CH8cyMeZWhk 2025-12-08T10:00:18+01:00 https://openregulatory.com/videos/free-course-understanding-unique-device-identifiers-udis-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/v11mdh3ci07nrloorzw0aqrfayvj?response-content-disposition=inline%3B%20filename%3D%22youtube_video_8ui7tnOOgfo_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_8ui7tnOOgfo_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=00dfa641c18a4ed24916cf1dfd20ef0aa76677de8676ad7ca9552e8ba228b9f1 Free Course: Understanding Unique Device Identifiers (UDIs) For Medical Devices In the first video of our free UDI course, we'll walk you through how UDIs are structured and how they work. https://www.youtube.com/watch?v=8ui7tnOOgfo 2025-12-05T10:00:13+01:00 https://openregulatory.com/videos/software-validation-iso-13485-qms-part-2 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/eux7vhxacixz0ays2qb84wqasv0y?response-content-disposition=inline%3B%20filename%3D%22youtube_video_bLg6u6okb4A_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_bLg6u6okb4A_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=ff4a8e9ada887a7eda8085fcdb369dd6bf72f1c502054d64dfa8ca095efdb674 Software Validation (ISO 13485 QMS), Part 2 Next, we'll look at the software validation form and how to fill it out. https://www.youtube.com/watch?v=bLg6u6okb4A 2025-12-04T09:00:49+01:00 https://openregulatory.com/videos/software-validation-as-part-of-your-qms-for-the-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ggaowv5q179c17z7ezqpj7gtoha8?response-content-disposition=inline%3B%20filename%3D%22youtube_video_YWit3E1EVbU_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_YWit3E1EVbU_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f5c9e5b87db75e77559db0e4c78970a45cc1efb55f4422bad3bacb5137d9ae49 Software Validation (as part of your QMS, for the ISO 13485) Let's take a look at how to validate software in the context of the ISO 13485. First, we'll look at the SOP. https://www.youtube.com/watch?v=YWit3E1EVbU 2025-12-03T09:00:57+01:00 https://openregulatory.com/videos/purchasing-supplier-checklist-for-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/tc9int3nxwhx8kyvfx138zj34sr0?response-content-disposition=inline%3B%20filename%3D%22youtube_video_3zqfRmuuP18_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_3zqfRmuuP18_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1c504013653891a59ca00cac9fbafc675c3e28ac4ea4bc81bae7a60f4e5212dd Purchasing: Supplier Checklist For ISO 13485 Compliance Let's continue our work on an ISO 13485 - compliant purchasing process. Next, we'll look at the supplier checklist! https://www.youtube.com/watch?v=3zqfRmuuP18 2025-12-03T09:00:04+01:00 https://openregulatory.com/videos/purchasing-sop-for-medical-devices-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/aqct6ib8vloazwfet4mrk3iqmf4j?response-content-disposition=inline%3B%20filename%3D%22youtube_video_sTLVkJc98nY_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_sTLVkJc98nY_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=9ac5075d5cbf92f2274641884bfe35bc3d25e95799c9ff15d113aeb43492b4fa Purchasing SOP For Medical Devices (ISO 13485) Let's look at how to structure your purchasing process at your medical device company in compliance with the ISO 13485. We'll look at the purchasing SOP first. https://www.youtube.com/watch?v=sTLVkJc98nY 2025-12-02T09:01:11+01:00 https://openregulatory.com/videos/human-resources-administration-for-medical-device-companies-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bznq5xt087vxav95xg7xv0zaonkl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_V0Yrzq-XC1A_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_V0Yrzq-XC1A_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7fbeb24af7a5ac30eb449b026c271689884fcc87dc3428c6201241b492d213c2 Human Resources Administration For Medical Device Companies (ISO 13485) Let's look at HR things! https://www.youtube.com/watch?v=V0Yrzq-XC1A 2025-12-01T09:00:43+01:00 https://openregulatory.com/videos/vigilance-for-eu-mdr-and-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/74tji11tt8yaypk24sr162y4mnvn?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Z2DLgeQdRkg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Z2DLgeQdRkg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=ea5c88e3db529e1c4018cd8c536d992d7c7ce2b3e2c1431065ad787b3d62b5fd Vigilance For EU MDR and ISO 13485 Compliance Vigilance is all about collecting data and doing the right thing after your product is on the market. https://www.youtube.com/watch?v=Z2DLgeQdRkg 2025-11-28T09:00:46+01:00 https://openregulatory.com/videos/capas-corrective-and-preventive-actions-for-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/unv9co4x5kkf8w7gi67rrl6h5rwe?response-content-disposition=inline%3B%20filename%3D%22youtube_video_QFtNczndfHA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_QFtNczndfHA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=bb79af3e4f1b41d49e0fa37b9915f8436c6cb23ba4a5052cff8e4aecbcfaeafd CAPAs (Corrective and Preventive Actions) For ISO 13485 Compliance CAPA stands for Corrective and Preventive Action. Find out more in the video! https://www.youtube.com/watch?v=QFtNczndfHA 2025-11-27T09:00:38+01:00 https://openregulatory.com/videos/eu-mdr-post-market-surveillance-part-2-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/prknk3i03f2mi2xanhsexf3rjlht?response-content-disposition=inline%3B%20filename%3D%22youtube_video_yfDI1oJdvMo_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_yfDI1oJdvMo_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=dab3d853fee0902e8e3b00348b2efe7ce01b82f32bee792a8b68485e53184dd9 EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485) Let's look at more post-market surveillance requirements for EU MDR and ISO 13485 compliance. https://www.youtube.com/watch?v=yfDI1oJdvMo 2025-11-26T09:01:18+01:00 https://openregulatory.com/videos/medical-device-technical-documentation-in-5-minutes-formwork-product-templates https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/k59fcma2vg52ym5f0ivjpctmlerx?response-content-disposition=inline%3B%20filename%3D%22youtube_video_cTOkQ94_GKc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_cTOkQ94_GKc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=c4f25683346e5e069d612dc0094338d50528ff5eb184d4fe0dbca91d21cde32b Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates When we learn to code, we learn by looking at example code on GitHub. Why don't we have examples for medical device technical documentation? Probably because people don't share them. https://www.youtube.com/watch?v=cTOkQ94_GKc 2024-10-08T08:17:42+02:00 https://openregulatory.com/videos/qms-automation-with-the-formwork-qms-overview https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/62t3ypsxcmgrg957kk3ovwseqg6x?response-content-disposition=inline%3B%20filename%3D%22youtube_video_JicUjIG14WE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_JicUjIG14WE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=11013dd46e5781cf40a5e67a8a7ab29dc719a8d5cd84668d50c127113de354d0 QMS Automation With The Formwork QMS Overview A quick walkthrough on how our eQMS software Formwork helps you automate your QMS documentation with a feature called the "QMS Overview". If you'd like to try out Formwork, check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=JicUjIG14WE 2024-09-23T16:26:01+02:00 https://openregulatory.com/videos/medical-device-qms-software-comparison-shady-business-practices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ga12ix233imnb4cvh3fsmn2yq8f7?response-content-disposition=inline%3B%20filename%3D%22youtube_video_zq8gBEZQ1cI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_zq8gBEZQ1cI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=8e8300d4582f8c347efd84b3f26b39a16eeb06c42ff50f3f3fa5058fbac9fbea Medical Device QMS Software Comparison: Shady Business Practices! Let me show you a medical device QMS software comparison and demonstrate how shady the industry is. And also, sorry for the Amazon box in the background. I'm currently tidying up! I also forgot to mention the most important points about our Formwork (chuckle): There's a free tier, and you get unlimited users in all tiers, which is super awesome! Anyway, here's the actual description of the video: Today, I'll walk you through different QMS software for medical devices. The general idea is that, if you're developing something like medical software, you have to certify it and companies usually purchase QMS software for this purpose. The problem, however, is that the industry is super shady. I'll show you why! If you're interested in Formwork, check it out here. And here's the link on how to set up a QMS in Google Drive. https://www.youtube.com/watch?v=zq8gBEZQ1cI 2024-05-23T04:18:17+02:00 https://openregulatory.com/videos/agile-development-for-medical-device-software-is-it-possible https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/mtxxbcbeofm0y70ufk1th911qr5s?response-content-disposition=inline%3B%20filename%3D%22youtube_video_FEwCNpYL0ew_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_FEwCNpYL0ew_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4f80d7990d65021f337ce74bbc9927dd2cf4779691c552316c14a36cccdff47f Agile Development For Medical Device Software: Is It Possible? This is the million-dollar question, or the Holy Grail of medical device compliance: Can you do agile development which magically generates all the necessary compliance documentation for your audits? I'll walk you through what's needed for passing audits, and based on a typical agile development process (ours!), we can take a look at whether it's possible. https://www.youtube.com/watch?v=FEwCNpYL0ew 2024-05-19T07:20:39+02:00 https://openregulatory.com/videos/get-notified-about-regulatory-updates https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ts2yy9bm1ro73vm480u9w8kztgp6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_X6dtPmIr_3M_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_X6dtPmIr_3M_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=d3d1b8e4d7ee56afaad9a6643922bc1fb0fe73df817d07034e400d603f95e51e Get Notified About Regulatory Updates In the past, learning about regulatory updates for staying up to date with medical device standards like the ISO 13485, IEC 62304 and others has either been very clunky or rather expensive. Today, we're launching Regulatory Updates in our eQMS software, Formwork, and the best thing is that we're making it available to everyone, for free! There's literally no reason not to use it - it'll save you lots of time, help you pass your audits and it's free. Check out Formwork here and sign up for a free account :) https://www.youtube.com/watch?v=X6dtPmIr_3M 2024-05-19T06:30:58+02:00 https://openregulatory.com/videos/jira-qms-can-you-set-up-a-qms-and-requirements-management-in-jira-for-medical-device-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/av12cx39p6stb9dlrq2l1v42859r?response-content-disposition=inline%3B%20filename%3D%22youtube_video_dbazbw2mT_g_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_dbazbw2mT_g_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4f8bc1f1a6ef281b6b9ccbab3f48f5851b8c811adaac24fc0ffaaa072e7328f3 Jira QMS: Can You Set Up a QMS And Requirements Management In Jira For Medical Device Compliance? As a medical device manufacturer, can you set up your Quality Management System (QMS) in Jira? And can you manage your requirements (e.g. Design Inputs) there, too? The goal would be compliance with the ISO 13485, IEC 62304 and other standards required for medical device manufacturers. Watch my video to see how a setup in Jira could look like, and where you might run into problems if you get audited. https://www.youtube.com/watch?v=dbazbw2mT_g 2024-05-16T10:38:07+02:00 https://openregulatory.com/videos/get-the-iso-13485-almost-for-free-how-to-buy-standards-on-the-estonian-website https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/fgg2swju1ik0qcb7uhm2ht0ft6bw?response-content-disposition=inline%3B%20filename%3D%22youtube_video_fpB8KPIVVFM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_fpB8KPIVVFM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=50de19581525f555fd056e027ab5c81029024a03095bd64e41de4438a3818d19 Get The ISO 13485 Almost For Free: How to Buy Standards on the Estonian Website You get the the ISO 13485 for free? If you're a medical device manufacturer, you have to comply with certain standards, like the ISO 13485. The shady thing, however, is that you have to buy those standards - yes, you literally have to purchase a PDF. The German websites offer standards for ridiculous prices - anywhere between 100€ and 600€, crazy! The good news is that other developed countries like Estonia are much more friendly towards innovation and offer them for much less money. In this video, I show you how you can purchase standards at the Estonian website. https://www.youtube.com/watch?v=fpB8KPIVVFM 2024-05-15T08:00:00+02:00 https://openregulatory.com/videos/bringing-transparency-to-mdr-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/5dp4cma1pr4s04jvlpue0wg369u0?response-content-disposition=inline%3B%20filename%3D%22youtube_video_f2UMlxCfvt0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_f2UMlxCfvt0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5d121feef5d5483bc8ab39c13dd1b15ef6bc3960ceb2dbfa8e26073d9be9eafc Bringing Transparency To MDR Compliance A quick mention of our templates and why we published them for free. Check out more here: https://openregulatory.com/templates/ https://www.youtube.com/watch?v=f2UMlxCfvt0 2024-04-30T18:43:39+02:00 https://openregulatory.com/videos/free-mdr-templates https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/sva9i38crs9oqx99pu46ww9r1i13?response-content-disposition=inline%3B%20filename%3D%22youtube_video_xm2maH9Vfg8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_xm2maH9Vfg8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=0c3b4d4ae66c66139be181a4aaeb8bc1b2fbb14251a250c2bbc2611ec8952501 Free MDR Templates A (very) short video about us offering free EU MDR templates and why the hell I came up with the idea :) Link: https://openregulatory.com/templates/ https://www.youtube.com/watch?v=xm2maH9Vfg8 2024-04-30T15:32:39+02:00 https://openregulatory.com/videos/software-detailed-design-documentation-in-formwork https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/u7c2xla8wk1elkhgtedcj45etpcd?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Mxe6dP42rLQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Mxe6dP42rLQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=ab283be5307bc160df66ed77ef064a1099e7503f15e2d0ccca6ade1c5457f852 Software Detailed Design Documentation in Formwork If you're IEC 62304 class C (there are classes A, B and C), you need to document something called "software detailed design" for your medical device. Let's check out how you can document that in Formwork, our QMS software. Check out Formwork here: https://openregulatory.com/ https://www.youtube.com/watch?v=Mxe6dP42rLQ 2024-04-08T22:25:01+02:00 https://openregulatory.com/videos/mdr-clinical-evaluation-understanding-the-process https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bqben8h5imlfsahaknv4y13d3j65?response-content-disposition=inline%3B%20filename%3D%22youtube_video_tRuPKvXPoPs_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_tRuPKvXPoPs_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=9b9e270167d741263814c8618a0b376d47eb50968eb6fb8d73b81d7ab86a6f37 MDR Clinical Evaluation: Understanding the Process This is the first video in our series of 7 videos on MDR Clinical Evaluations! Sebastian walks you through the process and basic concepts of an MDR Clinical Evaluation. He'll also walk you through the template of the Clinical Evaluation Process. This first video is free and all the other videos are purchasable through our Wizard video course which helps you bring your medical device to market and save lots of consultant fees. Check it out here: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=tRuPKvXPoPs 2024-02-28T07:22:05+01:00 https://openregulatory.com/videos/qms-overview-automate-your-iso-13485-documents-and-records https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/o58b5gd73z6m7q9iea7ouvzx2a4d?response-content-disposition=inline%3B%20filename%3D%22youtube_video_HmpzKtb0j-Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_HmpzKtb0j-Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=bb519fbc2a7823ca22403630d0baafbdf8b71bd8ead945d9753bd4fd517749d1 QMS Overview: Automate Your ISO 13485 Documents and Records Check out how Formwork automatically creates a document list of all your QMS documents, including SOPs and templates. This saves you a gigantic amount of time! To our knowledge, no other QMS software has anything which comes close. Formwork is the best software for medical device startups to bring their product to market. It comes with unlimited users and documents and even has a free tier! Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=HmpzKtb0j-Q 2024-02-26T07:35:39+01:00 https://openregulatory.com/videos/use-chatgpt-to-generate-your-qms-in-minutes https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/igznqokg3j2s4xw8z1ygxrgltqzr?response-content-disposition=inline%3B%20filename%3D%22youtube_video_G497IVVmoCA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_G497IVVmoCA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=65b230eab67f89d9ed03f9115acb1703e4de326df729a8e1695dd5119eaeb2a1 Use ChatGPT to Generate Your QMS In Minutes Check out how you can use ChatGPT to generate your entire ISO 13485 QMS from our free OpenRegulatory templates. If you're interested in using this yourself, check out Formwork, our QMS software: https://openregulatory.com/ https://www.youtube.com/watch?v=G497IVVmoCA 2023-11-30T15:28:59+01:00 https://openregulatory.com/videos/custom-file-documents-records https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/vuj6r8x3c9n5bnq34f5cwr8zqhw5?response-content-disposition=inline%3B%20filename%3D%22youtube_video_ZpBAcz4VP60_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_ZpBAcz4VP60_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=6f98efe1cb1e7822d9ee1e3ef072ffbc0c7c39d42ada37e1ee4a9843f4bc8e27 Custom File Documents / Records Migrating from another eQMS software can be tricky, but now it has become easier. In Formwork, you can now create new documents and records which are based on files. Learn more about Formwork here: https://openregulatory.com/ https://www.youtube.com/watch?v=ZpBAcz4VP60 2023-10-06T16:55:23+02:00 https://openregulatory.com/videos/qms-trainings-automatically-train-your-employees-in-formwork https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/uik57ke1uggb6yk2dpl6oqy3ud6e?response-content-disposition=inline%3B%20filename%3D%22youtube_video_03Nl4qXxCK0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_03Nl4qXxCK0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1662446cfa5c3048c45be30035ed347176a8ca028b70637f2ba99b5dda8e8664 QMS Trainings: Automatically Train Your Employees in Formwork See how Formwork enables you to save lots of time by automatically training your employees in your eQMS software - no need for clunky PDF files with electronic signatures! To learn more about Formwork, click this link: https://openregulatory.com/ https://www.youtube.com/watch?v=03Nl4qXxCK0 2023-10-06T16:45:37+02:00 https://openregulatory.com/videos/formwork-batch-export-the-only-eqms-software-without-lock-in https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/33alr7g70dnvv6otgvkygwc1ddj0?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Jwiw3EihJnI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Jwiw3EihJnI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=27887c441ba84237d762122c3d9085af5ad0e08e174479b7b74f4f8ff0de5e9f Formwork Batch Export: The Only eQMS Software Without Lock-In Take a look at how Formwork, our QMS software, enables you to take your data and export it at the click of a button. This is very useful if you want to hand in your documentation for audits or simply migrate to another system. To our knowledge, Formwork is the only QMS software with no lock-in: Export your data at a click of a button any time and cancel monthly with no contractual lock-in. To learn more about our eQMS software Formwork, click this link: https://openregulatory.com/ https://www.youtube.com/watch?v=Jwiw3EihJnI 2023-10-06T16:44:23+02:00 https://openregulatory.com/videos/manage-your-technical-documentation-in-formwork-eqms-software https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/gin4x0srelhgm3cc5ehbg7ezs97u?response-content-disposition=inline%3B%20filename%3D%22youtube_video_djsRz_QhFAI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_djsRz_QhFAI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e94abcc9edd8abbeae097d3cb3066ca098ce2e678dafef6f02fd2a6ab6c58cf2 Manage your Technical Documentation in Formwork (eQMS software) Formwork is not only an eQMS, but it also has requirements management features. Watch this video to learn the benefits of structured requirements management vs. doing everything in spreadsheets. To learn more about Formwork, click on this link: https://openregulatory.com/ https://www.youtube.com/watch?v=djsRz_QhFAI 2023-10-06T16:41:08+02:00 https://openregulatory.com/videos/chatgpt-for-medical-devices-and-automating-qms-trainings https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/5gvju0q8kdxrukkd9p93armjegok?response-content-disposition=inline%3B%20filename%3D%22youtube_video_hEAClCmRz-8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_hEAClCmRz-8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214909Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=b0bc0feca5fd5093071578a63f5d65d766ce68e8a6a20048c7b89d296dbd904e ChatGPT For Medical Devices And Automating QMS Trainings The third (and last) way to save a lot of time is to use LLM features and to automate your employee trainings for the ISO 13485. Let me walk you through how Formwork, our eQMS software, can pre-write your documentation with an LLM (like ChatGPT) and save you lots of time. Additionally, we'll look at how you can automate employee trainings for ISO 13485 compliance. https://www.youtube.com/watch?v=hEAClCmRz-8 2023-10-03T08:05:00+02:00 https://openregulatory.com/videos/auto-generate-audit-spreadsheets-for-requirements-management https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/4r0gbi4yaqqt850sbkz4rmhnjbnv?response-content-disposition=inline%3B%20filename%3D%22youtube_video_h2L1hLw7W6w_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_h2L1hLw7W6w_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a810319d9266585e3f67230398eaea0847d8feea7aeca34d2b15120df3d4fb78 Auto-Generate Audit Spreadsheets For Requirements Management When it comes to medical device compliance, where else can you save time and automate stuff? In your technical documentation - specifically, when it comes to requirements management for the IEC 62304. Let's take a look at how you can automate it. https://www.youtube.com/watch?v=h2L1hLw7W6w 2023-10-03T08:04:00+02:00 https://openregulatory.com/videos/save-time-by-copying-openregulatory-templates https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/p2qrv5x1smyb47rn6jj3dw94zr72?response-content-disposition=inline%3B%20filename%3D%22youtube_video_faBjThphOTU_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_faBjThphOTU_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e2e769f681b76839778ce9ed610b5dd35c565116e77f131a8c234cce8ea05bac Save Time By Copying OpenRegulatory Templates Here's what you can do next and save a lot of time: Use our free templates and free eQMS software, Formwork, too create a QMS in minutes, not days. https://www.youtube.com/watch?v=faBjThphOTU 2023-10-03T08:03:00+02:00 https://openregulatory.com/videos/how-to-get-regulatory-work-done-fast-hiring-eqms-software-consultants https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/qvaibs41rq8e5y5epi3kr2mrgfj8?response-content-disposition=inline%3B%20filename%3D%22youtube_video_BW_tSTAvE7A_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_BW_tSTAvE7A_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=9c2625cc86c7a3a81158ce39fd9aec37ea743eab322ce3568b9bee4f756d4d84 How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants Now you know the basics about medical device compliance. But what's next? Here's what you should do and what I talk about: • Finding someone who does the regulatory work • How to get everything done for free • When to use QMS software / eQMS software (not now!) • How we work as consultants with clients https://www.youtube.com/watch?v=BW_tSTAvE7A 2023-10-03T08:02:00+02:00 https://openregulatory.com/videos/what-do-you-need-to-do-looking-at-iec-62304-and-other-docs https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/q0my3a1a7b9rctt4op689rugl5l6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_v5h77LZby4Y_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_v5h77LZby4Y_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4ddc3d17245e5f96cb136d33bb59c0d946bf974c0a767bf15dd39170620d7e5d What Do You Need To Do? Looking At IEC 62304 And Other Docs Next, let's look at what the hell "medical device documentation" actually includes. I'll walk you through our templates and give you some examples of how you would fill them out. Things I cover: • ISO 13485 templates for quality management system documentation • IEC 62304 templates for software documentation • ISO 14971 templates for risk management documentation • IEC 62366 templates for usability documentation • Clinical evaluation templates for, you guessed it, clinical evaluation documentation https://www.youtube.com/watch?v=v5h77LZby4Y 2023-10-03T08:01:00+02:00 https://openregulatory.com/videos/medical-device-compliance-cost-duration https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/3r4r49hjl3l9i9elw42914zyhmaj?response-content-disposition=inline%3B%20filename%3D%22youtube_video_2wt4QIpBnfE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_2wt4QIpBnfE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=90b5c343612d5d6eb7b0f00df31d44da399a86b9005efc12e21f484863be4f41 Medical Device Compliance: Cost & Duration Are you a startup founder and wondering what the hell this whole "medical device compliance" thing is about? Look no further. We've worked with 100+ companies (and talked to many more!) and I've gathered all the frequently asked questions and their answers here for you. What I cover: • How much does it cost? • How long does it take? • Should you purchase QMS software (eQMS Software)? https://www.youtube.com/watch?v=2wt4QIpBnfE 2023-10-03T08:00:00+02:00 https://openregulatory.com/videos/getting-a-mdr-udi-from-ifa https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/e0ayt7zufvlta5le2ybgxqykfaqc?response-content-disposition=inline%3B%20filename%3D%22youtube_video_nkc-f5NDcoE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_nkc-f5NDcoE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4ae1c200ce274a00d159cea46a9d7f36920d8ebb6971ebcccbabeb28138ce1fe Getting a MDR UDI From IFA Getting a Unique Device Identifier (UDI) for your medical device is complicated. One of many problems is that you have to select a provider which "sells" you the UDI (it's about as shady as it sounds). There are a few providers on the market, and IFA is another one (we already talked about GS1 in another video). While you only have select one (no need to bother with both!), we've still gone through the process of getting a UDI with IFA, too, so you can pick and choose whatever provider you prefer. https://www.youtube.com/watch?v=nkc-f5NDcoE 2023-08-07T08:00:00+02:00 https://openregulatory.com/videos/getting-a-mdr-udi-from-gs1 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/pwiah2i3gwxjcc4wyx1p9jq2ylxy?response-content-disposition=inline%3B%20filename%3D%22youtube_video_ouZGZeQOUn0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_ouZGZeQOUn0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5019ce8e9631832f6a8aa4861ebe0886560435d5b5fbddf35f13e27b22d79d3e Getting a MDR UDI from GS1 Getting a Unique Device Identifier (UDI) for your medical device is complicated. One of many problems is that you have to select a provider which "sells" you the UDI (it's about as shady as it sounds). The first provider we'll talk about is GS1. We'll walk you through the steps you have to perform on the GS1 website for purchasing your UDI (spoiler: it's complicated, shady and terrible). https://www.youtube.com/watch?v=ouZGZeQOUn0 2023-08-01T08:00:00+02:00 https://openregulatory.com/videos/meet-crowdcovid-example-medical-device-software-for-iec-62304-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/hwxrkbd9s9y9rgrrleumi727ipjv?response-content-disposition=inline%3B%20filename%3D%22youtube_video_gDaj4K-XhB8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_gDaj4K-XhB8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=fa933202cbb864713805073ccca322614078f1e94effff3fa62e433a33c26efd Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance) When you develop software as a medical device (SaMD), your software needs to be developed and documented in an IEC 62304 - compliant way. So - what do you need to be IEC 62304 compliant? Well, I could give you an abstract talk about what's written in the regulation, or I could just show you an example software and we could see how we'd document it in a IEC 62304 - compliant way. So let's get started and look at CrowdCovid, the example application for your IEC 62304 documentation project. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=gDaj4K-XhB8 2023-07-26T12:24:29+02:00 https://openregulatory.com/videos/getting-started-with-the-iec-62366-usability-engineering-for-software-as-a-medical-device https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/a4q6ycw8gmjjw4cgona5u32hsqcj?response-content-disposition=inline%3B%20filename%3D%22youtube_video_AcgMmBZziqg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_AcgMmBZziqg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=98ece6c2dd240a8a621e38369e062a263358bec9f2c495989dac0acc621a6af2 Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device) A requirement for when you develop software as a medical device (SaMD) is that you have to be compliant with the IEC 62366, which is a standard about Usability. The long story short is that you have to do user testing and a few other things. And how do you do those things? Take a look at this video in which I give you an introduction. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=AcgMmBZziqg 2023-07-26T12:24:26+02:00 https://openregulatory.com/videos/how-does-the-iec-62304-v-model-work-for-software-development-of-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/vajxi96ruvihz30hhd6lhju9fcbj?response-content-disposition=inline%3B%20filename%3D%22youtube_video_DXf0tCLxy7Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_DXf0tCLxy7Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=12b05ecc70bbbe94d7e03645ab0d5cc97c1ae8cca6127881be53d2a67ed5bdb8 How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices? When you develop software as a medical device (SaMD), you have to develop and document it in a so-called IEC 62304 - compliant way. The IEC 62304 is a very lengthy PDF which, among other things, comes up with something called a "V-Model" for documenting software. So, what the hell is this V-Model? How does it compare to waterfall and agile development? This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=DXf0tCLxy7Q 2023-07-26T12:22:52+02:00 https://openregulatory.com/videos/medical-device-software-development-introduction-to-the-iec-62304 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/rlew95jzf5x6rcy7gcv3b3kqpqu6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_eGSaV5tH2c4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_eGSaV5tH2c4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=3f2d014a67fbddc1a9be45918e2747b8ba85d0aa597cd4d4fd62af1feabcb7ed Medical Device Software Development: Introduction To The IEC 62304 When you develop software as a medical device (SaMD), you have to develop and document it in a so-called IEC 62304 - compliant way. The IEC 62304 is a long PDF document and provides all sorts of (weird) requirements. Let's take a look at the IEC 62304 and how you can develop your medical device software in compliance with it. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=eGSaV5tH2c4 2023-07-26T12:22:21+02:00 https://openregulatory.com/videos/introduction-to-mdr-udis https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ylpo3s6du3m7xvbmari3xy2z8be5?response-content-disposition=inline%3B%20filename%3D%22youtube_video_hXTnSkb9xhg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_hXTnSkb9xhg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=df55efb79a797f5fce68243da648e6a5da58565be205d81e6aef008faaa04d00 Introduction To MDR UDIs As a medical device manufacturer, you have to provide Unique Device Identifiers (UDIs) for all your devices to be compliant with the MDR. The whole field is riddled with complicated instructions and weird providers. That's why we created a video course for you! We'll walk you through the exact steps you need to do to get your UDI for your medical device. We've literally purchased UDIs ourselves so you can see exactly which links you have to click on the websites of the UDI providers (GS1 and IFA). https://www.youtube.com/watch?v=hXTnSkb9xhg 2023-07-26T08:00:00+02:00 https://openregulatory.com/videos/hardware-medical-devices-in-formwork https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/yfte0znlef70l49ctlb099welj1w?response-content-disposition=inline%3B%20filename%3D%22youtube_video_aEjRtVI3xOI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_aEjRtVI3xOI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1f600718cb0a8556b08677f85a9b0aaf501051a02070cab54933c754038a0d98 Hardware Medical Devices in Formwork Check out how our eQMS, Formwork, now supports hardware medical devices. https://www.youtube.com/watch?v=aEjRtVI3xOI 2023-07-25T16:03:38+02:00 https://openregulatory.com/videos/formwork-vs-github-jira-clickup-asana https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ji801gwcv2fwbjoyh6inqhvlo6r1?response-content-disposition=inline%3B%20filename%3D%22youtube_video_8AWfX1VAS_A_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_8AWfX1VAS_A_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e869c823d9dc72bb3f9f0044fdb2da6863a2ea74345cd7341ae274e4ac51a41e Formwork vs GitHub, Jira, ClickUp, Asana Can you just use GitHub, Jira, or any other project management tool for your regulatory documentation? Yes - in theory, but there are a few things you should keep in mind. Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=8AWfX1VAS_A 2023-03-16T16:55:16+01:00 https://openregulatory.com/videos/ai-assisted-writing-of-technical-documentation https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/pq8ni0dpf6pkwd7jse7cluusiqag?response-content-disposition=inline%3B%20filename%3D%22youtube_video_e3a1mhDwMcA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_e3a1mhDwMcA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=3b55cfb73139e75dee8fe40bc4eb96337ffaa30bbf64d15673ed1d904e154474 AI-Assisted Writing of Technical Documentation Let's take a look at how we can automatically write Software Requirements (for the IEC 62304) and Software Tests with our eQMS software, Formwork. Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=e3a1mhDwMcA 2023-01-16T12:37:13+01:00 https://openregulatory.com/videos/manage-your-medical-device-capas-in-formwork-eqms https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/zzm5rwnz086r92meofksxcajr9g6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_3bP3z5xV9cE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_3bP3z5xV9cE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1cb131c6bc4690db04286b1046ecf40e597428d4786fcf4026298a52b5f46de7 Manage Your Medical Device CAPAs in Formwork (eQMS) CAPA stands for Corrective and Preventive Action. Check out how you can manage your CAPAs in a structured way in our eQMS software, Formwork! Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=3bP3z5xV9cE 2023-01-11T11:28:24+01:00 https://openregulatory.com/videos/formwork-auto-generate-your-technical-documentation-with-the-new-audit-export https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/k9z1dul74a8ni4nrdweh6wtpkx0z?response-content-disposition=inline%3B%20filename%3D%22youtube_video_H3BxGHSR6zY_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_H3BxGHSR6zY_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a135b256989dbb961d1857a462f76157f609bd722a4f00eecb2dc0bd93b85881 Formwork: Auto-Generate Your Technical Documentation With The New Audit Export Formwork's new audit export is really cool because it automatically generates spreadsheets for your technical documentation, based on the data you entered in Formwork. It's better than Jira, GitHub, GitLab and Notion because it's already pre-configured and doesn't jumble up your export layout. More information in our Formwork Feature Focus post here: https://openregulatory.com/formwork-generate-technical-documentation-automatically-audit-export/ Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=H3BxGHSR6zY 2022-10-31T09:56:14+01:00 https://openregulatory.com/videos/document-and-record-control-for-medical-device-quality-management-systems-iso-13485-qms https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/upi2tlxl4ugws7gahuoxntgwdz8m?response-content-disposition=inline%3B%20filename%3D%22youtube_video_bu2zTbeGkC0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_bu2zTbeGkC0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5ac8efcab1777275352cad76d62be407efcc2711ba400e65aa60c9eda59e14fd Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS) It's important to define how you handle your documents and records. Sounds weird, but it's actually quite easy! This is important, because you need these procedures to be compliant with the ISO 13485 which is required for medical device manufacturers. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=bu2zTbeGkC0 2022-09-08T09:50:07+02:00 https://openregulatory.com/videos/internal-audit-for-medical-device-manufacturers-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/kxzn7kkw7wnilz295rskdvbopn97?response-content-disposition=inline%3B%20filename%3D%22youtube_video_e_BoBwrEsf0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_e_BoBwrEsf0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=4c19b9d6187c1a950173fe249e91eacc5d7ac1c80f24800e2fe7fa2418b8f1e5 Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance) Doing regular internal audits is another requirement of the ISO 13485. You might think that this is over-engineered, especially for startups. Let's just say you're not alone. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=e_BoBwrEsf0 2022-09-08T09:50:02+02:00 https://openregulatory.com/videos/writing-a-quality-manual-for-medical-device-quality-management-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/yrq5kcw19ktyz5pucwf1m974e1r7?response-content-disposition=inline%3B%20filename%3D%22youtube_video_bj5uIWSBj68_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_bj5uIWSBj68_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=fd91d71cf2fa59690b85281c995af29682c8f65ff24ca28d423f126212622088 Writing a Quality Manual For Medical Device Quality Management (ISO 13485) Creating your ISO 13485 - compliant Quality Manual is the first step for setting up your Quality Management System (QMS) - and that itself is a requirement if you want to bring software as a medical device (SaMD) to market. This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=bj5uIWSBj68 2022-09-08T09:09:51+02:00 https://openregulatory.com/videos/the-magical-wizard-and-how-it-helps-you https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/zh2h9e5syng8ea78m2knqoizlkk1?response-content-disposition=inline%3B%20filename%3D%22youtube_video_kB6Ivg_FVrQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_kB6Ivg_FVrQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=190b631151df8a3c96c24f387713742c032838f7671e852e270cf7a6be7ed22e The Magical Wizard and How It Helps You The Wizard is a feature in Formwork which helps you create your medical device documentation in a fast and easy way. In this video, Oliver explains how it works. If you're interested in bringing your medical device software to market yourself in record time without expensive consultants, check out the Wizard here: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=kB6Ivg_FVrQ 2022-09-08T07:59:48+02:00 https://openregulatory.com/videos/samd-meetup-11-post-market-surveillance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/e02spl7frth9122u271afz5syz7h?response-content-disposition=inline%3B%20filename%3D%22youtube_video_KsncXoicVbg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_KsncXoicVbg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a1a835903bab2ce2b3786ef9b65e4cbb55d233aae78041ade766b09bdcd729fe SaMD Meetup #11: Post-Market Surveillance The 11th SaMD meetup was all about Post-Market Surveillance of, you guessed it, software as a medical device (SaMD). The SaMD meetup is hosted by Emma Knijn (Evidencio) and Jouke Waleson (easee). Speakers: Paul Theunissen (GreyRA) Sven Piechottka (OpenRegulatory) Content: 00:00 Introduction 03:47 Talk by Paul Theunissen 14:10 Talk by Sven Piechottka https://www.youtube.com/watch?v=KsncXoicVbg 2022-06-15T09:51:21+02:00 https://openregulatory.com/videos/automate-your-medical-device-risk-management-with-formwork-an-eqms-iso-14971-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bfomucwhwkdf800xhn92uw1jmzhy?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Vy9kfQUiPtA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Vy9kfQUiPtA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=cd501467abb589a53013a66279fc68a1c7a891b4737555730a9ba4bb47a84c17 Automate Your Medical Device Risk Management With Formwork, An eQMS (ISO 14971 Compliance) I you're developing medical software (or rather, software as a medical device), you have to perform something called risk management, and you have to adhere to a standard called ISO 14971. Confused at what those things are? No worries, just watch this video to see how our software makes it much easier for you. Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=Vy9kfQUiPtA 2022-05-24T18:10:10+02:00 https://openregulatory.com/videos/audit-export-and-sanity-check https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/25fmuif7kjqkfjx3adesool5h6j4?response-content-disposition=inline%3B%20filename%3D%22youtube_video_LobhXXFuBBo_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_LobhXXFuBBo_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1a44f791e1de76d6cac37d6d6bb3bc9eebc66767626e990eb7815b24d0081933 Audit Export and Sanity Check This is a slightly-outdated video describing our old audit export. It has been superseded by this video with our fancy new audit export, check it out: https://youtu.be/H3BxGHSR6zY https://www.youtube.com/watch?v=LobhXXFuBBo 2022-05-24T18:10:08+02:00 https://openregulatory.com/videos/iec-62304-compliant-software-requirements-specification-for-software-as-a-medical-device-samd https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/uxccqc283phpbx48qk99kvqxidld?response-content-disposition=inline%3B%20filename%3D%22youtube_video_bPcKgVeAA7Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_bPcKgVeAA7Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=412c9ec2058ce1cd44b6d4408faf12bd65feff65c4ce00df01d7aeb0c8627a01 IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD) When developing software as a medical device (SaMD), you have to document something called "Software Requirements". That's an ancient term for describing your software features. And there's a standard for that, the IEC 62304 (a lengthy PDF document) which tells you how you document those. Confused? The good news is that we've developed a software which helps you document those requirements in a compliant way. Watch this video to learn more! :) Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=bPcKgVeAA7Q 2022-05-24T18:10:05+02:00 https://openregulatory.com/videos/employee-qms-training-for-iso-13485-compliance-using-eqms-software https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/6w7czy2w63tcfppf2wfchw6179ct?response-content-disposition=inline%3B%20filename%3D%22youtube_video_pFe7Jy84XJ4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_pFe7Jy84XJ4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=171207afa81035c8aa1f39b17c9e8897a1df56981d6c7f7fcf31154799dd7055 Employee QMS Training For ISO 13485 Compliance, Using eQMS Software One requirement of the ISO 13485 for quality management is that you have to prove that all people in your organisation (employees etc.) have been trained on your internal procedures. Without software, this is a huge pain because you have to manually do training sessions with everyone (in person or remote), and then you have to collect signatures from all attendees (again, remotely or in person). eQMS software offers a lot of potential for automation in this area - you can literally perform compliant trainings in seconds, and not hours. Check it out! Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=pFe7Jy84XJ4 2022-05-24T18:10:03+02:00 https://openregulatory.com/videos/iso-13485-compliant-handling-of-records-save-time-using-openregulatory-templates https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ofrhdth2fry32n1pdkj9nwppienl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_8NKgypeP8j0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_8NKgypeP8j0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=89322a98df906056e0d5675159c4295cc8319e376a89d9b82883d7437d3fb463 ISO 13485 - Compliant Handling Of Records, Save Time Using OpenRegulatory Templates The ISO 13485, the standard for quality management for medical device manufacturers, differentiates between documents and records. Let's look at what records are in this video. You'll also learn how you can speed up your compliance documentation drastically by using our templates which are built into the software - and free! Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=8NKgypeP8j0 2022-05-24T18:10:00+02:00 https://openregulatory.com/videos/fda-and-eu-complaint-e-signatures-documents-and-review-workflow-in-eqms-software-formwork https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/hyzlbxmfa8ze538xxqpi24n2m4mr?response-content-disposition=inline%3B%20filename%3D%22youtube_video_24h6FeDYwgE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_24h6FeDYwgE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=8df5cba996c962f5ff7934e48b68b3eb6ed539429d923929aa7e8460e4061e42 FDA and EU - Complaint E-Signatures: Documents and Review Workflow in eQMS Software Formwork Sending documents out for review is a crucial step for medical device compliance. Most importantly, if you're planning to enter the US market, the FDA has additional requirements for compliant e-signatures. Watch this video to learn how eQMS software helps you automate this, saving you lots of time in the process. Are you interested in shipping your medical software faster? Check out Formwork: https://openregulatory.com/ https://www.youtube.com/watch?v=24h6FeDYwgE 2022-05-24T18:09:56+02:00 https://openregulatory.com/videos/introducing-formwork https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/y9r9xbmbvhkgoeh6katqrtlcggvi?response-content-disposition=inline%3B%20filename%3D%22youtube_video_WG45Qwk45kc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_WG45Qwk45kc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=fffdba54855725f6cce79ed450e64e3415133eefc50af15ea7198e67af65f9f6 Introducing Formwork Today, we're launching our compliance software, Formwork. After briefly talking about why we developed it, I'll walk you through some of it's features! :) Check out the Formwork page on our website for more information: https://openregulatory.com/ https://www.youtube.com/watch?v=WG45Qwk45kc 2022-04-07T17:25:11+02:00 https://openregulatory.com/videos/openregulatory-workshop-at-digital-medicine-conference-2021 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/06yh9r8ox22lpfrtxhtr168p7cyt?response-content-disposition=inline%3B%20filename%3D%22youtube_video_7a7pasDr1kA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_7a7pasDr1kA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=ea64b0f09f046cea6847312b2dd1a271305034bcf859f99cd8fddeaeca0245b8 OpenRegulatory Workshop at Digital Medicine Conference 2021 This was a workshop held by us at Digital Medicine Conference 2021 (https://dmc.hih-2025.de/en/home/). It was a hybrid event with in-person group activities. The idea was to give each group a real-world task, like "write an intended use" or "do a risk analysis". For that, we came up with a (made-up) app which would be a medical device - the hugely innovative rheumatism correlator! The workshop was in German language. https://www.youtube.com/watch?v=7a7pasDr1kA 2021-12-22T13:19:40+01:00 https://openregulatory.com/videos/documenting-failure-modes-for-iso-14971-risk-management-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/okpnqi3da42cs8wj7tbaejhh7tsl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Wp0lSBHSr0Q_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Wp0lSBHSr0Q_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=c636a3a55ad7a069cd4919680494c04d86754d6ae133f03be1aa4201040d9529 Documenting Failure Modes for ISO 14971 (Risk Management For Medical Devices) What could possibly go wrong in our software? We'll learn about software failure modes in the context of a FMEA: - How to associate Failure Modes with software systems - How to link up Failure modes with the Hazards in our FMEA and analyze them further. Here's our FMEA template: https://openregulatory.com/fmea-risk-table-template-iso-14971/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=Wp0lSBHSr0Q 2021-05-09T13:25:43+02:00 https://openregulatory.com/videos/failure-mode-and-effects-analysis-fmea-for-iso-14971-risk-management-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/nhe4726km0jwwhwaqum047bl59zr?response-content-disposition=inline%3B%20filename%3D%22youtube_video_zsAcXpD6pf0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_zsAcXpD6pf0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=10c55be0bd4003193faf0f58ef0b6358efff7a63b552827b7d2878248b4a1250 Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices) We'll attempt to transform our freestyle simple Risk Table to a full-blown FMEA. Along the way, we'll be learning about: - Understanding Hazards, Hazardous Situations and Harms - Understanding intermediate probabilities (p1 and p2) and how to use them - How to use our Severity Categories - How to decide whether a risk is acceptable or not - A Usability Hazard. Wikipedia article on FMEA with a pretty good explanation and examples: https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis Our FMEA template: https://openregulatory.com/fmea-risk-table-template-iso-14971/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=zsAcXpD6pf0 2021-05-09T13:22:11+02:00 https://openregulatory.com/videos/creating-a-simple-risk-table-for-iso-14971-risk-management-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/zc07ttxfmiexbp56gxflbnmyh7pr?response-content-disposition=inline%3B%20filename%3D%22youtube_video_aqE9yxscuTo_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_aqE9yxscuTo_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=8881e68c91c507e98adc46c498e693a125c09a12e777ed0bf080b0bbe563f34b Creating a Simple Risk Table for ISO 14971 (Risk Management For Medical Devices) Let's get started with something straightforward: Thinking about what could possibly go wrong. We'll be creating a simple risk table which will (hopefully) end up being a full-blown Failure Mode and Effects Analysis (FMEA): - How to define failure modes (in a simple way). - Thinking about the medical impact (what will happen in the end?). - Very roughly estimating probability and severity. Check out the Wikipedia article on FMEA with a pretty good explanation and examples: https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis And here's our FMEA template - we don't need this now, but in a later video when our FMEA table is more complete :) https://openregulatory.com/fmea-risk-table-template-iso-14971/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=aqE9yxscuTo 2021-05-08T12:58:17+02:00 https://openregulatory.com/videos/creating-a-list-of-hazard-related-use-scenarios-for-iec-62366-usability-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/5tlifht696ca63haedq9lgi843k4?response-content-disposition=inline%3B%20filename%3D%22youtube_video_gUT3OnuDZWc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_gUT3OnuDZWc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=c4bfdb74e3b0d00944afe1014bfda88d61df139d49006a87653b3e2d15bae3ae Creating a List of Hazard-Related Use Scenarios for IEC 62366 (Usability For Medical Devices) Let's dive right into it and write down Hazard-Related Use Scenarios for the magic Covid Photo App. Hazard-Related Use Scenarios are (usage) scenarios in which Hazards could arise (sounds obvious, right?). We'll see whether we can come up with some scenarios for the magic Covid Photo App and how to document them. We'll also learn about other core use scenarios you may have to cover for 13485 compliance. Resources Template: List of Hazard-Related Use Scenarios Here's the obligatory link to our template for the List of Hazard-Related use Scenarios: https://openregulatory.com/list-of-hazard-related-use-scenarios-template-iec-62366/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=gUT3OnuDZWc 2021-05-08T12:53:26+02:00 https://openregulatory.com/videos/preparing-the-usability-evaluation-protocol-for-iec-62366-medical-device-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bul3krmhvnkqkn8r6ukjrpsyycxs?response-content-disposition=inline%3B%20filename%3D%22youtube_video_1JsLfe36_QA_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_1JsLfe36_QA_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f4e7010e6b4beb81c059b7c65d9a6c42f2a2568ed4ff96adc6f12a1efeeca8cc Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance) We need to prepare before we get into the most important part, the User Test for our Summative Evaluation. We need a list of tasks with instructions and acceptance criteria before heading into our user test! We'll learn: - How to "convert" the List of Hazard-Related Use Scenarios to tests in the Usability Evaluation Protocol. - How to avoid the most common problem: Writing Software System Tests. - How to come up with useful instructions and acceptance criteria. - How many tests to have for each Hazard-Related Use Scenario. And finally, here's the link to our template: https://openregulatory.com/usability-evaluation-protocol-template-iec-62366/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=1JsLfe36_QA 2021-05-08T12:51:42+02:00 https://openregulatory.com/videos/writing-a-software-development-and-maintenance-plan-for-iec-62304-medical-device-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/a8w0lf6n4my6sntsyf8b1a1w9bar?response-content-disposition=inline%3B%20filename%3D%22youtube_video_09aHvrb7UK8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_09aHvrb7UK8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=13bf01eccb5e5f372682586fbc62373b65623cffc024024ce4d0969a71a1474b Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance) Let's write a Software Development and Maintenance Plan for CrowdCovid. We start writing our first regulatory document. Exciting! Let's go through the template for the Software Development and Maintenance Plan, talk about these things and fill them out while doing so: - Relevant processes: The processes you'll be using during your software development. - Programming languages: The programming languages your software is written in (and how to document them). - Development software: The development software you're planning to use, e.g. your IDE. - System requirements / target runtime: Where your code will be executed including hardware requirements for your server. - "Avoiding common software defects based on selected programming technology": How to come up with a reasoning to fulfil this 62304 requirement. - Configuration management and version control - Documentation activities - Verification activities - Software system test activities Check out the template for the Software Development and Maintenance Plan on our website: https://openregulatory.com/software-development-maintenance-plan-template-iec-62304/ This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information: https://openregulatory.com/courses/the-wizard/ https://www.youtube.com/watch?v=09aHvrb7UK8 2021-05-08T12:21:29+02:00 https://openregulatory.com/videos/documenting-software-of-unknown-provenance-soup-for-iec-62304 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/3s8476yxyh9trdgw1u2cywpfnxen?response-content-disposition=inline%3B%20filename%3D%22youtube_video_z-hq1-d3m3g_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_z-hq1-d3m3g_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=3fe39218e778ad11d89bbe52fe6f369519f91792719480af78ace98576d216c9 Documenting Software of Unknown Provenance (SOUP) for IEC 62304 Ready for some pain? We need to document our libraries because they're SOUP. SOUP stands for Software of Unknown Provenance. In human language, those are your libraries. Nowadays, these are open-source libraries which you include in your package.json or Gemfile. But how do you document it? It depends on your IEC 62304 software safety class again. For class A, it's pretty uncomplicated. For class B and C, it gets more tricky, so we'll see what needs to be done. First, we'll do it for the backend Ruby code by going through our Gemfile and documenting Rails as SOUP. After that, we'll look into the package.json of the JavaScript code and document a library from there. We'll cover: - What to document for each library. - What to use as "anomaly list" and how to evaluate it. - How to introduce a risk classification of SOUP - How to specify SOUP requirements - How to verify SOUP without doing tests (i.e. writing code) yourself Finally, I'll explain the point of SOUP documentation while reducing my ranting to a local minimum. Check out the SOUP list template on our website: https://openregulatory.com/soup-list-template/ https://www.youtube.com/watch?v=z-hq1-d3m3g 2021-05-08T12:17:08+02:00 https://openregulatory.com/videos/dr-oliver-eidel-bei-der-digital-medicine-week-2021-vom-health-innovation-hub-hih https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ib9n0e4wl2t12h9n3zkkuxv1us9b?response-content-disposition=inline%3B%20filename%3D%22youtube_video_NaSJXaCWqXk_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_NaSJXaCWqXk_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a4fa5053b9174e9e9b08aaed9d085e9e52dfcc430549bc5781ca222619d1811e Dr. Oliver Eidel bei der Digital Medicine Week 2021 vom health innovation hub (hih) Oliver ist Arzt, Software-Entwickler und Berater und erzählt ein paar Geschichten aus Healthcare-Startups, die Medizinprodukte konform entwickeln wollten. Anschließend überlegt er, wie man regulatorische Compliance mit OpenRegulatory weniger schmerzhaft gestalten kann. Zum Schluss gibt er den Zuschauern noch drei schnelle Tipps von Mutti. Der Vortrag war Teil der Digital Medicine Week (DMW) 2021, einer (virtuellen) Konferenz vom health innovation hub (HIH). Weitere Informationen zur Digital Medicine Week: https://dmw.hih-2025.de OpenRegulatory-Webseite: https://www.openregulatory.com 0:00 Vorstellung durch Jan Brönneke 1:12 Warum bin ich hier? 5:52 Zwei echte Geschichten aus Startups 12:06 Wie können wir Compliance weniger schmerzhaft gestalten? 17:58 OpenRegulatory Templates und Community 19:55 Drei schnelle Tipps von Mutti 23:41 Tschüß https://www.youtube.com/watch?v=NaSJXaCWqXk 2021-03-04T11:13:33+01:00 https://openregulatory.com/videos/free-course-quality-management-for-medical-devices-iso-13485-qms https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/k3lprjv59jh7tzeqj6s700xyejjv?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Y2PnlXMzr7E_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Y2PnlXMzr7E_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=15ddf1c740afa708f666e2e6bfaf4bd1fe12ba0667e4e723c52f790bf252b6b6 Free Course: Quality Management For Medical Devices (ISO 13485 QMS) Introduction to our free course on quality management for medical devices in accordance with the ISO 13485! You'll learn how to set up your quality management system (QMS) and we'll show you how to fill out our free templates along the way. If you haven't yet, check out Formwork, the most affordable eQMS software for medical devices: https://openregulatory.com/ https://www.youtube.com/watch?v=Y2PnlXMzr7E 2025-11-14T09:00:49+01:00 https://openregulatory.com/videos/free-usability-engineering-course-medical-devices-iec-62366 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/e25x9xlnocdtkkt6kaaq8v5f2ihk?response-content-disposition=inline%3B%20filename%3D%22youtube_video_roJuWmzisIk_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_roJuWmzisIk_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7c9f19b040024986d5a0960718731ee0a1a8cecf634bd43b0d4bf0f6dcb40d79 Free Usability Engineering Course (Medical Devices - IEC 62366) Join us for our free course on medical device usability engineering (IEC 62366) which we've published to YouTube, completely free, no strings attached! You'll learn everything you need to know to bring your medical device to market and achieve compliance with the IEC 62366 which is the standard for usability engineering for medical devices. 00:00 Introduction 01:09 Getting the standard, avoiding the "standards mafia" 02:15 Recap of prior documentation 05:23 Documenting user needs and stakeholders As mentioned in the video, here's how you get standards from the friendly Estonian site: https://www.youtube.com/watch?v=IYQGrDmE_Cg The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=roJuWmzisIk 2025-11-03T09:30:20+01:00 https://openregulatory.com/videos/free-medical-device-risk-management-course-introduction-simple-risk-table-iso-14971 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/rbyuutqec806y925fhqbhcl6fogg?response-content-disposition=inline%3B%20filename%3D%22youtube_video_XcdIRDh5Ek8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_XcdIRDh5Ek8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=b07fa93dac1e44839864a21abdec1e9e7abf50fa9f21001d9e7fdb6eb8fb536a Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971) In the first video of our free ISO 14971 risk management course, I'll walk you through how a simple risk analysis would work. We'll start from first principles without reading the standard line by line (boring!). 00:00 Introduction 00:38 Recap of prior documentation (IEC 62304 course) 02:12 Simple risk table (Google Sheets!) 07:49 Risk acceptance 09:17 Risk controls Check out Formwork, our eQMS software which helps you automate your medical device compliance: https://openregulatory.com/ Check out the OpenRegulatory website for free medical device compliance templates: https://openregulatory.com https://www.youtube.com/watch?v=XcdIRDh5Ek8 2025-10-14T13:30:06+02:00 https://openregulatory.com/videos/free-iec-62304-course-documenting-software-as-a-medical-device-samd https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/anv8dehtdi2m9q9cpnvco8sdxw6h?response-content-disposition=inline%3B%20filename%3D%22youtube_video_1zT00eXy-6o_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_1zT00eXy-6o_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=270c24f55bc3c6064238c4e9d05c8e702b13b56f3dafb0f3a42700a80e361a19 Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD) 00:00 Introduction 01:15 Getting the standard at evs.ee 04:34 Getting stuck Our awesome new IEC 62304 course! Learn how to document your software as a medical device (SaMD) in a compliant way to get certified as per the EU MDR. The IEC 62304 is the standard for software as a medical device, and following it is one of the biggest chunks of work when it comes to bringing a software medical device to market. We've updated the entire course in 2025 and re-recorded every video. Enjoy! Head over to https://openregulatory.com for free EU MDR templates and our awesome eQMS software :) https://www.youtube.com/watch?v=1zT00eXy-6o 2025-02-10T23:02:36+01:00 https://openregulatory.com/videos/chatgpt-for-medical-device-documentation-mdr-fda https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/hapww8vck5x4s18vt3mtkija41jd?response-content-disposition=inline%3B%20filename%3D%22youtube_video_ccEBPWeuen0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_ccEBPWeuen0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=544e7d4758a7c8a507113317e4a2217250f0a9eb17f3a6b84a5beb8eb02052c8 ChatGPT For Medical Device Documentation (MDR / FDA)? Can you use ChatGPT to create your medical device documentation for EU MDR or FDA submissions? We'll find out in today's video :) 00:00 Introduction & free templates! 01:23 First attempt with ChatGPT 03:56 Second attempt with Formwork 06:35 Conclusion https://openregulatory.com/ https://www.youtube.com/watch?v=ccEBPWeuen0 2024-04-15T14:33:41+02:00 https://openregulatory.com/videos/leander-markisch-building-ai-for-radiology-at-floy-healthcare-startup-meetup-1 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/rwgf3ndarse6hz8yh5oltx8kbs60?response-content-disposition=inline%3B%20filename%3D%22youtube_video_bZVivAZUNNw_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_bZVivAZUNNw_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f78ff8b4637fc0f9980fb1e470aa63a6a253afca237a414123b68909500c9e7a Leander Märkisch: Building AI For Radiology at Floy (Healthcare Startup Meetup #1) Episode 1 of our Healthcare Startup Meetup! If you want to join next time, check it out here: https://www.meetup.com/healthcare-startup-meetup/ Watch Leander Märkisch, Co-Founder and "Chief Plumber" of Floy, talk about Building AI For Radiology and moving fast in highly-regulated environments. For our first meetup, my thoughts were like "let's choose an average speaker to try things out". Shortly later, I was like "screw it" and messaged Leander whether he'd be willing to do a talk! So, to be clear, Leander is no average speaker, and the company he co-founded, Floy, is certainly no average company. It's probably one of the hottest Radiology AI companies in Europe right now, and rightly so! They've recently raised their series A at 5.4 million Euros after their pre-seed rounds of 3.4 million. They've gained a lot of attention for growing fast, too - they state that they've captured 14% of the German Radiology market. Leander describes himself as CTO and "Chief Plumber" and will share his experiences in a 20-minute talk. We'll also hang around a bit afterwards to give you a chance to ask questions to Leander and do some networking! https://www.youtube.com/watch?v=bZVivAZUNNw 2024-02-05T05:09:52+01:00 https://openregulatory.com/videos/document-and-record-control-for-the-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/xgf6hhbqgccdrfsdmu14ovykut3z?response-content-disposition=inline%3B%20filename%3D%22youtube_video_1HgPxmMR5T4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_1HgPxmMR5T4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5ffa71384c6d6110810294e866928ce72150be1204443cfe1fadd4692ad5a82e Document and Record Control For The ISO 13485 The ISO 13485 is the standard for quality management for medical devices. It has some very specific ideas on how you should manage your documents and records. We'll walk you through how to set that up in a compliant way! If you haven't yet, check out Formwork, the most affordable eQMS software for medical devices: https://openregulatory.com/ https://www.youtube.com/watch?v=1HgPxmMR5T4 2025-11-17T09:00:02+01:00 https://openregulatory.com/videos/medical-device-usability-engineering-writing-user-tests-summative-evaluation-of-iec-62366 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/lrd7u2hvpko8z3vgeveto71mgwo5?response-content-disposition=inline%3B%20filename%3D%22youtube_video_EKBQm-BNWm4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_EKBQm-BNWm4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=3e9eda7547fc5571a6d411d773d7747d2953db5b633ac8b667b8d704402ee57a Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366) In the second video of our free medical device usability engineering course, we'll be creating some user tests. Those fulfill the requirement of conducting a "summative evaluation" as per the IEC 62366, which is the usability engineering standard for medical devices. 00:00 Introduction & recap 02:20 Creating our first user test 10:07 Creating our second user test 10:50 Google Sheets would be hell The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=EKBQm-BNWm4 2025-11-05T09:30:06+01:00 https://openregulatory.com/videos/medical-device-risk-analysis-risk-matrix-iso-14971 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/8c35caawu18kg8wn0yo4c7l7aov7?response-content-disposition=inline%3B%20filename%3D%22youtube_video_k5n3OWv_yjM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_k5n3OWv_yjM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=08f3d28a563724d90cbce22d6de86f903b3faf9ae29d80bb26ffbb9f1a5f85f5 Medical Device Risk Analysis: Risk Matrix (ISO 14971) We've performed a simple risk analysis in our Google Sheet, but now we have to make everything a bit more structured, and creating a risk matrix is the next step! This will enable us to define which combination of probabilities and severities are acceptable. 00:00 Introduction 01:07 Simple risk table recap 02:05 Numerical probabilities 04:33 Defining medical harm in severities 05:33 Simple risk matrix 09:20 A better risk matrix The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=k5n3OWv_yjM 2025-10-15T11:45:09+02:00 https://openregulatory.com/videos/ai-qms-where-chatgpt-fails-cybersecurity-requirements https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/rn7w4xhwhznbp4teerkw8n7rwpvt?response-content-disposition=inline%3B%20filename%3D%22youtube_video_cTXfd9zV5aM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_cTXfd9zV5aM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=53942837823a4f687922e1b488056e40c57d6ae4dfe7557bf45b6e4ebca094ad AI QMS: Where ChatGPT Fails (Cybersecurity Requirements) Where does AI fail for medical device QMS writing? Let's take a look at one example where you still need real humans to edit QMS documents, chuckle.. 00:00 Introduction 01:08 Shady IEC sales page 01:32 Editing SOP with AI 04:45 Fails By the way, even though it didn't work out too great in this video (haha), the chat-based rewriting eQMS feature is available right now on all our plans, including our free plan! For even more AI features, upgrade to one of our paid plans starting at only 99€ / month. If you're interested, check out our QMS software, Formwork: https://openregulatory.com/ Subscribe to our channel for more AI and medical device content! :) https://www.youtube.com/watch?v=cTXfd9zV5aM 2025-07-22T10:45:05+02:00 https://openregulatory.com/videos/actually-getting-the-standard-iec-62304-course-episode-2 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/kh5azy8vqeca2tqbxku4qqborfx6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_IYQGrDmE_Cg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_IYQGrDmE_Cg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=21700dcffc48eac207f8f642576762e3a359499cc33e97d9e36444fce8d10ca0 Actually Getting The Standard (IEC 62304 Course Episode 2) 00:00 Trying to purchase the standard again 00:45 Taking a first look 03:13 Why you need templates (use our free ones) 06:50 The mapping table In this episode, I try (again) to purchase and download the IEC 62304 standard, which is a PDF file. After succeeding, I show you what it's all about and how medical device compliance roughly works. We'll look at why you need templates (ugh) and how you can use our free templates to save lots of time and money (nice) :) Check out our website https://openregulatory.com for more! https://www.youtube.com/watch?v=IYQGrDmE_Cg 2025-02-17T12:15:00+01:00 https://openregulatory.com/videos/matthew-fenech-diga-for-glucose-control-at-una-health-healthcare-startup-meetup-2 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/p10wlstbvx7plkxywji5oiaf1c61?response-content-disposition=inline%3B%20filename%3D%22youtube_video_S1LKoeJWpxQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_S1LKoeJWpxQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=05643aa415da0db1879b7386f9815def1efa724651013d115b6d78981765f16d Matthew Fenech: DiGA For Glucose Control at Una Health (Healthcare Startup Meetup #2) 00:00 Introduction 03:02 Matt's talk 18:00 Q&A Episode 2 of our Healthcare Startup Meetup! If you want to join next time, check it out here: https://www.meetup.com/healthcare-startup-meetup/ In this meetup, our guest will be Matthew Fenech from Una Health. I can hardly believe that he managed to carve some time out of his schedule to join us, because many exciting things are happening at his company Una Health right now! Matt co-founded Una Health and is its Chief Medical Officer. The company's product, an app for glucose control for diabetics, recently gained approval as a DiGA in Germany which means that public health insurance reimburses it. And if that already isn't cool enough, I think the product of Una Health makes it even more exciting. They use data from continuous glucose monitors (CGM) to track the blood sugar (glucose) values of their patients, and then give recommendations regarding nutrition and exercise. Matt will give us a brief introduction on Una Health. After that, we'll move on to the Q&A format which was really popular last time, so feel free to prepare your questions for Matt! If you're considering founding a Healthcare Startup, this is your chance! :) Matthew “Matt” Fenech is a doctor by training. Before co-founding Una Health in 2021, Matt worked at a think tank called Future Advocacy and as Medical Safety Lead at Ada Health. He also worked as a doctor in the NHS and did his PhD in Molecular Biology. https://www.youtube.com/watch?v=S1LKoeJWpxQ 2024-04-04T16:35:00+02:00 https://openregulatory.com/videos/certification-and-product-registration-process https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/9gv78fp6pyeq3mh7gs7et5416r3u?response-content-disposition=inline%3B%20filename%3D%22youtube_video_RK1GPpNVJq4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_RK1GPpNVJq4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=b745b0232ddeecaf62803771a307ec6e3f9a09d9092b1a5dc07e92eb0406b430 Certification and Product Registration Process How to you certify and register your medical device as part of your ISO 13485 - compliant quality management system (QMS)? We'll show you how it's done. If you haven't yet, check out Formwork, the most affordable eQMS software for medical devices: https://openregulatory.com/ https://www.youtube.com/watch?v=RK1GPpNVJq4 2025-11-18T09:00:29+01:00 https://openregulatory.com/videos/doing-the-summative-usability-evaluation-user-tests-medical-device-compliance-iec-62366 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/w6r1zzo7g8hneuijn3hfmwjt9uab?response-content-disposition=inline%3B%20filename%3D%22youtube_video_waJ93RrhZbE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_waJ93RrhZbE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=7484a0eaaf944704f42933f96834799a2704174383a1f0ab3ef21c84a87bc144 Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366) The IEC 62366 requires us to do something called a "summative usability evaluation". For normal humans, this means conducting a user test. Let's look at how you could conduct a user test for a software medical device and document it in a way which contains all the relevant information which auditors expect to see. 00:00 Introduction & recap 01:32 IEC 62366 requirements (summative evaluation) 03:53 Executing user tests with humans 05:27 How cool is this 08:56 Doing another user test The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=waJ93RrhZbE 2025-11-07T09:30:36+01:00 https://openregulatory.com/videos/risk-tables-are-easy-medical-device-risk-analysis-iso-14971 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/hrn5eu2q3propcj3iolydcpzrmgw?response-content-disposition=inline%3B%20filename%3D%22youtube_video_CUz8Msik3ic_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_CUz8Msik3ic_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=ebceea53fc5ccfd362c24e2d983998cf762ec74979a703e317310f47cacc26db Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971) Time to create our first risk table entry! What's a risk table, anyway? Luckily, Formwork will guide us in creating the right entries for our risk table - hazards, hazardous situations and harms. All the things we need to perform an ISO 14971 - compliant risk analysis for our medical device! Technically, what we're doing here is a failure modes and effects analysis (FMEA), but the simple name would just be "risk analysis". 00:00 Introduction 01:14 Recap & risk table 02:44 Defining harms 06:47 Defining hazards & hazardous situations 10:05 Probabilities 11:52 Success, automatic risk matrix look-up The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=CUz8Msik3ic 2025-10-17T11:30:10+02:00 https://openregulatory.com/videos/chatgpt-qms-for-editing-documents-fix-audit-findings https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/gpdxo1zpryqblowwnzyw4kyb62hx?response-content-disposition=inline%3B%20filename%3D%22youtube_video_46W2fbKs2d8_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_46W2fbKs2d8_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=417514b35224101af86795a04d84f32b23d91b53f61083ab9c25d422fbaa01c6 ChatGPT QMS For Editing Documents (Fix Audit Findings) Let's take a look at how you can easily edit your QMS documents with an integrated AI, just like with ChatGPT. In contrast to ChatGPT however, our AI can directly propose changes to your documents. We'll look at a very specific example of fixing a real-world audit finding which we've received from the Berlin medical device authorities in the past. 00:00 Introduction 01:43 Editing the post-market surveillance SOP 02:30 Editing with AI 04:01 Also editing the post-market surveillance plan 05:08 Conclusion and limitations 07:05 Availability & pricing This feature is available right now on all our plans, including our free plan! For even more AI features, upgrade to one of our paid plans starting at only 99€ / month. If you're interested, check out our QMS software, Formwork: https://openregulatory.com/ Subscribe to our channel for more AI and medical device content! :) https://www.youtube.com/watch?v=46W2fbKs2d8 2025-07-17T10:06:36+02:00 https://openregulatory.com/videos/understanding-the-iec-62304-safety-classes-and-the-mysterious-v-model https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/9ber0cn4kkm6wsb3tm1ibff786fr?response-content-disposition=inline%3B%20filename%3D%22youtube_video_DgMT-pstXYI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_DgMT-pstXYI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=07a50d939d32112cd9fd5c150e50fde20823feeee0be81251ac14c83aa849d75 Understanding the IEC 62304 Safety Classes and the Mysterious V-Model 00:00 Documentation differences for 62304 safety classes 01:19 Determining your 62304 safety class 05:18 Understanding the V-Model The most important starting point for your IEC 62304 compliance is your 62304 software safety classification. Depending on whether your software is A, B or C, you have to fulfill difference documentation requirements. We'll take a look at how to classify your software here. After that, we'll attempt to understand the V-model of software development. This is a way of developing software which regulators came up with and is completely detached from reality. Check out our website https://openregulatory.com for more! The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=DgMT-pstXYI 2025-02-24T11:45:01+01:00 https://openregulatory.com/videos/b2b-sales-and-generating-revenue-tatyana-eliseeva-healthcare-startup-meetup-3 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/v0v632c83bwtjilyik4ejxnixj1z?response-content-disposition=inline%3B%20filename%3D%22youtube_video_lEpZcCYF2HM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_lEpZcCYF2HM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=f4861d06057b10d8458e31a1abce9b33f1af9fe74f9a7bf9cb28fed78a8f18de B2B Sales And Generating Revenue: Tatyana Eliseeva, Healthcare Startup Meetup #3 00:00 Introduction 02:30 Tatyana's Talk 20:30 Q&A Our Healthcare Startup Meetup is back! This time, we'll be focusing about one of your most-requested topics: B2B sales and generating revenue. If you want to join next time, check it out here: https://www.meetup.com/healthcare-startup-meetup/ Tatyana from HealthCaters will be our guest, and she'll be sharing her insights on those topics with you in our popular Q&A format in which you can ask her your questions. HealthCaters is a Berlin-based Healthtech startup founded by Dr. Lilia Kruse and Tatyana Eliseeva. The company focuses on democratizing disease prevention by offering accessible and affordable 360° health assessments for companies. Recently, HealthCaters secured €1.2 million in seed funding to increase its reach both in Germany and internationally. Tatyana is the co-founder of HealthCaters. She has a Master's degree in economics. Before founding HealthCaters in 2020, she worked as an investment analyst and head of business development. She co-founded HealthCaters together with Lila Kruse who is a medical doctor. Tatyana will give us a brief overview over HealthCaters, and after that we'll move to our popular Q&A format in which you can ask Tatyana your questions. In this session, we'd like to focus on the topic of B2B sales and generating revenue, so if you're interested in that, this meetup is for you! https://www.youtube.com/watch?v=lEpZcCYF2HM 2024-08-12T12:20:50+02:00 https://openregulatory.com/videos/management-reviews-for-iso-13485-compliance-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/e7qsq28s7z252bwcf01z5ioo895a?response-content-disposition=inline%3B%20filename%3D%22youtube_video_R8ps-1oYMw0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_R8ps-1oYMw0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=9e14ba0e13fe1ae2d90a8a66fa11a68aacdd6a3db3b1032a4ee97e3ba09d4dbf Management Reviews For ISO 13485 Compliance (Medical Devices) As a startup with a huge headcount, it's important to review your management regularly. https://www.youtube.com/watch?v=R8ps-1oYMw0 2025-11-19T09:00:37+01:00 https://openregulatory.com/videos/formative-evaluation-for-usability-compliance-iec-62366-for-medical-devices https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/39ehwufdtl0u04ckapfg51jep8p5?response-content-disposition=inline%3B%20filename%3D%22youtube_video_twatdSGjqoE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_twatdSGjqoE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=196c758882e4b20653676c974a83dee06a6d4158600a099f27ec275de68e44b3 Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices) Besides doing a summative evaluation, the IEC 62366 (the standard for usability engineering for medical devices) also mentions something called a "formative evaluation". It's optional, but it's useful. I'll show you an example of a formative evaluation and how you can document it in an efficient way. 00:00 Introduction 02:40 Doing an example formative evaluation The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=twatdSGjqoE 2025-11-10T09:30:36+01:00 https://openregulatory.com/videos/medical-device-failure-modes-iso-14971-risk-analysis https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/huwtg1fvahh978celjwbq30c86ru?response-content-disposition=inline%3B%20filename%3D%22youtube_video_86POkJhq4xc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_86POkJhq4xc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=627a59e8ebd808005b3bf85b11b9c631d09ebe4fe920dd71cf859faa84ea4c22 Medical Device Failure Modes (ISO 14971 Risk Analysis) As always, we skipped ahead a few steps for the sake of getting something done and not getting bogged down in nitty-gritty details. Now, let's catch up on what we've missed: Our fancy ISO 14971 - compliant risk analysis of our medical device also needs to include failure modes, so that's what we'll be documenting in this video. The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=86POkJhq4xc 2025-10-20T11:45:03+02:00 https://openregulatory.com/videos/risk-management-with-ai-1-000x-faster-in-seconds https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/zq33181w6od9aw6j9s7vuxii8wym?response-content-disposition=inline%3B%20filename%3D%22youtube_video_vggPL-frBPI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_vggPL-frBPI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=03b7fd3ebc37d76af82ecbfc2e4e68b19d34f34a3569887c340bdc8cd2c1c069 Risk Management With AI: 1,000x faster! (in seconds) 00:00 AI Magic (risk management) 00:23 Introduction 1:20 Doing risk management the old way 8:04 Risk management with AI (1,000x faster) 11:54 Formwork availability & pricing How can you use AI for your medical device risk management? Today, we'll look at a brand new feature in our eQMS software, Formwork, which enables you to use AI for your risk management and do it 1,000x faster. Essentially, it creates your risk table for you, by creating hazards, hazardous situations and harms, and tying them all together in a risk table. This feature is available right now on all our plans, including our free plan! For even more AI features, upgrade to one of our paid plans starting at only 99€ / month. If you're interested, check out our QMS software, Formwork: https://openregulatory.com/ Subscribe to our channel for more AI and medical device content! :) https://www.youtube.com/watch?v=vggPL-frBPI 2025-07-08T14:33:00+02:00 https://openregulatory.com/videos/writing-software-requirements-for-iec-62304-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/iccp771ivlph7rxh3g1c2p5z2bm6?response-content-disposition=inline%3B%20filename%3D%22youtube_video_Z02Na7nSDco_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_Z02Na7nSDco_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=b6566ca6ff0a32e77f80d8f7372fc4504e6e03afbc3153e2c9998fa0d7c312d2 Writing Software Requirements For IEC 62304 Compliance 00:00 Choosing an example: MindDoc 01:45 Documenting software requirements with a template (terrible) 05:24 A better way (Formwork eQMS) 09:39 Adding another system and software requirement 11:35 Understanding relations and creating a user need 14:25 Versioning 15:39 Creating another software requirement 16:50 Creating a Stakeholder 17:35 The requirements overview 18:36 The magical audit export 20:25 Don't over-engineer From the perspective of regulators, software is developed not by writing code, but by sitting in a dark room, smoking cigars and writing software requirements. This is not necessarily close to reality in 2025, but we will still go ahead and write software requirements, because that's what the IEC 62304 wants us to do. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=Z02Na7nSDco 2025-03-03T11:45:02+01:00 https://openregulatory.com/videos/internal-audits-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/cq47bm5vc6githaednv2daau3nxl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_mJ8nZ8lSOM4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_mJ8nZ8lSOM4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=449a1d47b30c8cd8472077c44015fc1efaa67f93da9d004fd1c6ff7fbdf6e522 Internal Audits (ISO 13485 Compliance) Doing regular internal audits is another requirement of the ISO 13485. You might think that this is over-engineered, especially for startups. Let's just say you're not alone. https://www.youtube.com/watch?v=mJ8nZ8lSOM4 2025-11-20T09:01:04+01:00 https://openregulatory.com/videos/usability-evaluation-plan-report-finalizing-medical-device-usability-compliance-iec-62366 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ml08kuwtezl1g157b5wdkhnrzqjc?response-content-disposition=inline%3B%20filename%3D%22youtube_video_GDgC_FerNck_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_GDgC_FerNck_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=47ed212046874650b70a0189f645fbff507cd83e20449256dd87f7e4f37fc85d Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366) We're 95% done with our usability compliance documentation for our medical device. Now we just need to wrap up the missing pieces which mostly boils down to the bureaucratic busywork of filling out rich-text document templates to make our auditors happy. I'll walk you through filling out the so-called usability evaluation plan and report. 00:00 Introduction & recap 01:22 Copying over usability evaluation templates 02:42 Usability evaluation plan walkthrough 05:21 Usability evaluation report walkthrough 06:58 Audit export 09:41 Usability course wrap-up The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=GDgC_FerNck 2025-11-12T10:00:32+01:00 https://openregulatory.com/videos/risk-controls-make-your-life-easier-medical-device-risk-management https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/bs32v40abfv570sg28mgiy55zfts?response-content-disposition=inline%3B%20filename%3D%22youtube_video_8E_H8WcZS10_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_8E_H8WcZS10_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=6b99eb0b1c0e9b8ae2bd1636cbb08e1b31f74cb202c274f52babd1303f3164e6 Risk Controls Make Your Life Easier (Medical Device Risk Management) What do you do if a risk is not acceptable in your risk analysis? Easy - just randomly change your probabilities. Just kidding. The correct answer, of course, is to consider risk controls and add them to your medical device. That's exactly what we'll be doing in this video, with the goal of further completing our ISO 14971 - compliant risk analysis of our medical device. The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=8E_H8WcZS10 2025-10-22T09:00:06+02:00 https://openregulatory.com/videos/ai-powered-eqms-100x-faster-trainings https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/m5e70asmhjih9835tglddz9tptu0?response-content-disposition=inline%3B%20filename%3D%22youtube_video_mF6sa85PDSc_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_mF6sa85PDSc_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=78c8d8def8f6dfcb0cb01f0d3ebd8dee91966d12d5bd107af34248f072b8e31c AI-Powered eQMS: 100x Faster Trainings! 00:00 Magical QMS questions appear 00:26 Introduction 1:12 Creating a training the old way 3:48 Clunky quiz creation 4:38 Magical AI-assisted quiz creation 6:00 Formwork availability & pricing Watch how an AI-powered eQMS can save you hours of work by automatically creating your QMS trainings for you. Instead of manually creating employee training quizzes the old way, which can easily take hours, our eQMS, Formwork, creates them in seconds with its AI integration. Interested in Formwork? Check it out here: https://openregulatory.com/ Subscribe to our channel for more medical device AI content :) https://www.youtube.com/watch?v=mF6sa85PDSc 2025-07-03T11:25:44+02:00 https://openregulatory.com/videos/software-test-documentation-for-iec-62304-compliance-medical-device-software https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/zl2ft810eeu1nxd8q9ljmud2x7t9?response-content-disposition=inline%3B%20filename%3D%22youtube_video_PnpIaJUMC2Y_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_PnpIaJUMC2Y_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=8cfb51d758a33e34f3f4e55b39bf51849bd8470a275f5802ce6a3b88fc967604 Software Test Documentation For IEC 62304 Compliance (Medical Device Software) 00:00 Introduction 01:15 Looking into the IEC 62304 03:19 Looking at our templates 08:02 Using our eQMS Formwork 13:21 Can you automate this in your code? 20:44 Did we cover everything? 21:25 Exporting for your audit In this video, you'll learn how to document your medical device software tests in a IEC 62304 - compliant way. First, we'll look at what sort of documentation auditors expect, then I'll show you how you can automate things and speed them up. Finally, we'll export everything so that you can hand in a neat spreadsheet to your auditors :) The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=PnpIaJUMC2Y 2025-03-10T11:45:01+01:00 https://openregulatory.com/videos/feedback-management-for-medical-device-iso-13485-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/higeebp3n0werjgvw5qzt1o2joz3?response-content-disposition=inline%3B%20filename%3D%22youtube_video_G1sEjG9C6gE_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_G1sEjG9C6gE_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=a9cd8870d92dc22906caa80e47585f6787a8ef148e3460f340c8cfb21681adf2 Feedback Management For Medical Device (ISO 13485) Compliance The 13485 requires you to have a process in place to manage the feedback of your customers. Let's have a look at that. https://www.youtube.com/watch?v=G1sEjG9C6gE 2025-11-24T09:00:21+01:00 https://openregulatory.com/videos/linking-up-failure-modes-and-risk-controls-medical-device-risk-analysis https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/m1ywwu184byk9ha5xpt0nuo85u8g?response-content-disposition=inline%3B%20filename%3D%22youtube_video_cx3GLrlFww4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_cx3GLrlFww4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=01fa23aee5f3825c50061bcc90884d71c2841688a8f9bd6a1bf68ac02febc2c9 Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis) We've created failure modes and risk controls (awesome!), but we actually have to link them correctly in our documentation as otherwise our efforts were in vain (painful!). So that's what we're going to do. Failure modes need to be linked to hazards, and risk controls can be linked to software requirements, software tests, or user tests. All of this is in line with what the ISO 14971 states for medical device risk management. The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=cx3GLrlFww4 2025-10-24T09:00:46+02:00 https://openregulatory.com/videos/documenting-soup-software-of-unknown-provenance-for-iec-62304-and-medical-device-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/54f3xk2m36ka7pewapev1x3ovied?response-content-disposition=inline%3B%20filename%3D%22youtube_video_ovVqssqFLF4_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_ovVqssqFLF4_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=033ab9ba0bb82a9a037c952f186069f03416a3fcd0a5be0281947cd0b22c9b17 Documenting SOUP (Software of Unknown Provenance) For IEC 62304 and Medical Device Compliance 00:00 SOUP documentation is useless 01:32 What does the IEC 62304 say? 02:59 How does the template look like? 05:13 How to do it in Formwork 08:39 How to fill out the columns 13:33 What do auditors look at? As part of your medical device and IEC 62304 compliance, you have to document so-called Software of Unknown Provenance (SOUP). This activity doesn't make any rational sense. I'll walk you through it anyway. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=ovVqssqFLF4 2025-03-17T11:45:03+01:00 https://openregulatory.com/videos/eu-mdr-post-market-surveillance-part-1-iso-13485 https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/nndeavrsy2zcqww5xci7xzb25ae3?response-content-disposition=inline%3B%20filename%3D%22youtube_video_28TpSVFwdwU_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_28TpSVFwdwU_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=5b2e15b6c1fb7510422a52ce6d3a37b2481102faa9b59f893d12fe9f88eff64c EU MDR Post-Market Surveillance, Part 1 (+ ISO 13485) Let's look at post-market surveillance requirements for EU MDR and ISO 13485 Compliance https://www.youtube.com/watch?v=28TpSVFwdwU 2025-11-25T09:00:05+01:00 https://openregulatory.com/videos/hazard-related-use-scenarios-risk-analysis-for-medical-devices-usability-engineering https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/wle8fl5h96ntqslypepeoz2vprs0?response-content-disposition=inline%3B%20filename%3D%22youtube_video_oir1rk-pKME_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_oir1rk-pKME_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=797a6553ae93787346eae557571db523889c327fdfc0e0c7fc0f474dd714ac71 Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering) Hazard-related use scenarios are a weird thing where two standards for medical device compliance overlap: The ISO 14971 (risk management) and the IEC 62366 (usability engineering). In short, you have to analyze which of the use scenarios of your device might lead to hazards. Luckily, documenting that is very easy if you're using the right software (guess which one I'm using). So in this video, I'll walk you through documenting user needs and related hazards, resulting in hazard-related use scenarios. The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=oir1rk-pKME 2025-10-27T09:00:54+01:00 https://openregulatory.com/videos/writing-a-software-development-and-maintenance-plan-for-iec-62304-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/srraec3ua2tizsdleaotpz5qob5n?response-content-disposition=inline%3B%20filename%3D%22youtube_video_A9aXF0RaN0I_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_A9aXF0RaN0I_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=405f50e8c923a2d23306ed317436a4f4fb94c902db001b66b750c55a627e5141 Writing a Software Development and Maintenance Plan For IEC 62304 Compliance 00:00 Regulators have weird ideas 01:12 Looking at the template 01:45 Creating it in Formwork 03:55 Filling out the software development plan 08:50 Saving it and versioning Another requirement of the IEC 62304 is that you "plan" your development. The typical way to comply with this is by writing a Software Development and Maintenance Plan. Suffice to say, it's not the most interesting activity, but I'll show you how to do it in this video. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=A9aXF0RaN0I 2025-03-24T11:45:00+01:00 https://openregulatory.com/videos/no-one-does-preliminary-hazards-analysis-mostly-iso-14971-medical-device-risk-analysis https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/nfjf7vzdhrsnt20vpzclfxsjpg3y?response-content-disposition=inline%3B%20filename%3D%22youtube_video_jvXnUhjbzg0_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_jvXnUhjbzg0_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=38e65daeb5a88da35abe8865ab311ee47a53e70d9e0b36f9c6efa9b4c700d025 No One Does Preliminary Hazards Analysis (Mostly) (ISO 14971 Medical Device Risk Analysis) Theoretically, the ISO 14971 requires you do do a preliminary hazards analysis (PHA) as part of your medical device risk analysis. The reality is that companies tend to "forget" about this and do it later. And that's fine, as long as you do it - your documentation will be complete, and your auditor will be happy. Accordingly, in this video, I'll show you how to do a preliminary hazards analysis (minimalistic approach, as always). The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here: https://openregulatory.com/ https://www.youtube.com/watch?v=jvXnUhjbzg0 2025-10-29T09:15:08+01:00 https://openregulatory.com/videos/iec-62304-compliant-software-development-process-sop-software-development https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/2dxdko7u8az2zg06wsra727jiytl?response-content-disposition=inline%3B%20filename%3D%22youtube_video_DpWp3u4hyGo_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_DpWp3u4hyGo_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=34d24b1c8268001230ddbebf597d8af94832a5d7af34a29cbb362783144e8bde IEC 62304 - Compliant Software Development Process (SOP Software Development) 00:00 Extremely boring introduction 01:00 I am a terrible teacher 03:03 The template 06:49 Creating it in Formwork 08:20 How to fill it out If you're developing software as a medical device, for IEC 62304 compliance, you have to document your software development process (among other things). I'll walk you through an example documentation for that - we call it the SOP Integrated Software Development and it's as fancy as it sounds. Check out our website https://openregulatory.com for more! The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=DpWp3u4hyGo 2025-03-31T12:45:00+02:00 https://openregulatory.com/videos/iso-14971-wrap-up-sanity-check-ai-descriptions-risk-management-plan-report https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/vxgzglsfanponemqwhy4jk0apr12?response-content-disposition=inline%3B%20filename%3D%22youtube_video_gn7BhJmqehQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_gn7BhJmqehQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=aa023833e6a995cd826796bcc0957bc0a90142c34239ae9d1783dcf3e76dd213 ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report Let's wrap up the risk management course! In the final video, we'll be using Formwork's smart features to see what we're missing in our documentation. We'll also be filling out the risk management plan and risk management report. Luckily, Formwork comes with free templates, so we can just copy-paste them and fill in the missing pieces. Check out Formwork, our eQMS software, the most affordable compliance software for medical device documentation - it includes all the free templates (risk management plan and report) shown in the video: https://openregulatory.com/ Links to the document templates for the risk management plan and risk management report shown in the video (note that you can also use them within Formwork, which is much easier - these are only the Microsoft Word / PDF files): Risk management plan: https://openregulatory.com/document_templates/risk-management-plan-and-risk-acceptance-matrix Risk management report: https://openregulatory.com/document_templates/risk-management-report https://www.youtube.com/watch?v=gn7BhJmqehQ 2025-10-31T08:45:05+01:00 https://openregulatory.com/videos/software-architecture-for-medical-device-software-iec-62304-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/cdbxyjfcfjwhu3ifzo55rzwkhjko?response-content-disposition=inline%3B%20filename%3D%22youtube_video_RmuaRqk5ofQ_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_RmuaRqk5ofQ_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=1f4d76c6894f8c728ca92f2a4e87a4ce9ede714efe91c6f3a6a7b2f43ce9404f Software Architecture For Medical Device Software (IEC 62304 Compliance) 00:00 Introduction 01:14 Example: German Covid App 02:45 A better approach 08:04 Stay pragmatic 09:10 Swagger documentation When developing software as a medical device, the IEC 62304 also requires you to document your software architecture. In most cases, this boils down to creating a document which is somewhat clunky. I'll walk you through the clunky document in this video. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=RmuaRqk5ofQ 2025-04-07T12:45:01+02:00 https://openregulatory.com/videos/software-release-and-review-final-tasks-for-iec-62304-compliance-for-software-as-medical-device https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/b720kr3anqs4kmt447bb8tp07l6g?response-content-disposition=inline%3B%20filename%3D%22youtube_video_JArPTuIMWzI_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_JArPTuIMWzI_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=e7faf85f182d76d4ccd88393791c12e794000af4f1039b88fd8bc4de1b51ab06 Software Release and Review: Final Tasks For IEC 62304 Compliance For Software as Medical Device 00:00 We're not done? 00:59 Releasing records 02:50 Stakeholder documentation 04:20 Actually fixing the stakeholder 06:53 Adding software tests 07:58 Adding software test runs 09:10 Adding user tests 12:01 Reviewing requirements 18:35 Releasing it! 20:10 How do you do it with other software? Releasing your software as a medical device is probably the biggest step of your medical device (and IEC 62304) compliance journey. Today we're taking it. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=JArPTuIMWzI 2025-04-14T12:45:04+02:00 https://openregulatory.com/videos/change-management-for-software-as-a-medical-device-iec-62034-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/83r014nk34ivjibzq0hjha20h843?response-content-disposition=inline%3B%20filename%3D%22youtube_video_touySoTI-Rg_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_touySoTI-Rg_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=375e93430e63365a398f47a57729ddc508396b087463acc82f1d5a4968280cc1 Change Management For Software as a Medical Device (IEC 62034 Compliance) 00:00 Creating a new release 01:45 Changing a software requirement 03:17 Creating a new software requirement 04:11 Creating a change request 07:58 Significant changes (MDCG 2020-3) 13:05 How to do this without Formwork (templates) Your software as a medical device is released and you're IEC 62304 compliant - cool! What now? Now you have to track all changes to your software and document them, too (great). They IEC 62304 calls this "change management". It's very fun. We'll be doing it today. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=touySoTI-Rg 2025-04-21T12:45:11+02:00 https://openregulatory.com/videos/jira-github-integration-machine-learning-docs-known-anomalies-finishing-iec-62304-compliance https://openregulatory-website.a4f29e78cf09474013060c0e0c7dfbf7.eu.r2.cloudflarestorage.com/ju46kofpygt50p8ulyu0h46sbt0q?response-content-disposition=inline%3B%20filename%3D%22youtube_video_rme0nNSCpMM_thumbnail.jpg%22%3B%20filename%2A%3DUTF-8%27%27youtube_video_rme0nNSCpMM_thumbnail.jpg&response-content-type=image%2Fjpeg&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=429755df99f4e550fdaab6e11a3cb470%2F20260603%2Fauto%2Fs3%2Faws4_request&X-Amz-Date=20260603T214910Z&X-Amz-Expires=300&X-Amz-SignedHeaders=host&X-Amz-Signature=c0ae487966984e7aeb25da38cf08d64a76a61163c014406371e3796167dacaf9 Jira / GitHub Integration, Machine Learning Docs, Known Anomalies (Finishing IEC 62304 Compliance) 00:00 Going through the mapping table 02:30 Machine learning templates 03:33 List of known anomalies 05:20 SOP Change Management, SOP Deployment, SOP Problem Resolution 07:17 Jira / GitHub Integration 10:36 Hardware devices & detailed design 16:40 End of the IEC 62304 course! This is the final video of our free IEC 62304 course. Mad props for watching this far without falling asleep! In this video, I'm wrapping up with some missing bits and pieces and commonly asked questions, most importantly whether to integrate your eQMS with Jira and GitHub. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/ https://www.youtube.com/watch?v=rme0nNSCpMM 2025-04-28T01:00:48+02:00 https://openregulatory.com/users/dr-oliver-eidel 2026-06-03T10:54:43+02:00 monthly 0.5 https://openregulatory.com/users/ale-solano 2025-06-01T14:39:03+02:00 monthly 0.5 https://openregulatory.com/users/saurabh-sikchi 2026-04-27T17:34:39+02:00 monthly 0.5 https://openregulatory.com/users/sebastian-skorka 2026-05-31T21:02:28+02:00 monthly 0.5 https://openregulatory.com/conference2021_talks/jouke-waleson-whats-so-hard-medical-devices-for-consumers 2025-06-01T14:39:23+02:00 never 0.4 https://openregulatory.com/conference2021_talks/natascha-cuper-kiva-dare-common-findings-in-samd 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/johannes-tanne-git-for-qms-document-control 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/pat-baird-ai-medical-device-global-update 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/oliver-eidel-opening-talk 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/ben-meier-internal-audit 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/ivo-flipse-software-requirements-management 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/martin-witte-digitalization-of-technical-documentation 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/kicky-van-leeuwen-ai-in-radiology-current-state 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/audience-questions-and-discussion 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/astrid-ottosen-supplier-evaluation-medical-annotators-ai-samd 2025-06-01T14:39:21+02:00 never 0.4 https://openregulatory.com/conference2021_talks/oliver-eidel-agile-development-of-medical-devices 2025-06-01T14:39:22+02:00 never 0.4 https://openregulatory.com/conference2021_talks/leon-doorn-risk-management-decision-support-systems 2025-06-01T14:39:22+02:00 never 0.4