# OpenRegulatory
> Medical device QMS software, consulting, and free templates for lean, founder-led companies.

OpenRegulatory provides Formwork, an AI-powered eQMS (electronic Quality Management System) for medical device compliance. The company also publishes free document templates, articles, Q&A, and videos covering EU MDR, IVDR, FDA, ISO 13485, IEC 62304, ISO 14971, and IEC 62366.

## Formwork (eQMS Software)
- [Formwork](https://openregulatory.com/): AI-powered eQMS for medical device compliance. ISO 13485, EU MDR, IVDR and FDA.
- [Pricing](https://openregulatory.com/pricing): Free, 99 EUR, or 499 EUR/month. Cancel any time.
- [Testimonials](https://openregulatory.com/testimonials): Customer stories from companies that passed audits with Formwork.

## Articles
- [Top 7 AI Prompts To Automate Your QMS (MCP)](https://openregulatory.com/articles/top-7-ai-prompts-to-automate-your-qms-mcp): [plain text](https://openregulatory.com/articles/top-7-ai-prompts-to-automate-your-qms-mcp.text)
- [DMEA 2026 Thoughts: DiGAs Dead, More Scribes, Fewer Startups](https://openregulatory.com/articles/dmea-2026-thoughts): [plain text](https://openregulatory.com/articles/dmea-2026-thoughts.text)
- [Matrix Requirements Alternative: What Companies Choose](https://openregulatory.com/articles/matrix-requirements-alternative): [plain text](https://openregulatory.com/articles/matrix-requirements-alternative.text)
- [Dot Compliance Alternative: Better Fits For Faster-Moving Teams](https://openregulatory.com/articles/dot-compliance-alternative): [plain text](https://openregulatory.com/articles/dot-compliance-alternative.text)
- [MasterControl Alternative: Better Options For Medical Device Startups](https://openregulatory.com/articles/mastercontrol-alternative): [plain text](https://openregulatory.com/articles/mastercontrol-alternative.text)
- [SoftComply Pricing: Confusing (Just Like Jira)](https://openregulatory.com/articles/softcomply-pricing-confusing-just-like-jira): [plain text](https://openregulatory.com/articles/softcomply-pricing-confusing-just-like-jira.text)
- [MasterControl Pricing: Beyond Crazy](https://openregulatory.com/articles/mastercontrol-pricing): [plain text](https://openregulatory.com/articles/mastercontrol-pricing.text)
- [Why We Share Our Templates For Medical Device Compliance For Free](https://openregulatory.com/articles/why-we-share-our-templates-for-medical-device-compliance-for-free): [plain text](https://openregulatory.com/articles/why-we-share-our-templates-for-medical-device-compliance-for-free.text)
- [The eQMS Graveyard: Enzyme Got Acquired](https://openregulatory.com/articles/eqms-graveyard): [plain text](https://openregulatory.com/articles/eqms-graveyard.text)
- [Don't Use Risk Priority Numbers In Your Risk Analysis (ISO 14971)](https://openregulatory.com/articles/don-t-use-risk-priority-numbers-in-your-risk-analysis-iso-14971): [plain text](https://openregulatory.com/articles/don-t-use-risk-priority-numbers-in-your-risk-analysis-iso-14971.text)
- [Why We're Publishing Our 30-Page EU MDR Roadmap For Free](https://openregulatory.com/articles/why-we-re-publishing-our-30-page-eu-mdr-roadmap-for-free): [plain text](https://openregulatory.com/articles/why-we-re-publishing-our-30-page-eu-mdr-roadmap-for-free.text)
- [Can You Use the OpenAI API In Your Medical Device?](https://openregulatory.com/articles/can-you-use-the-openai-api-in-your-medical-device): [plain text](https://openregulatory.com/articles/can-you-use-the-openai-api-in-your-medical-device.text)
- [Clinical Evaluation Report: Literature Search - SaMD](https://openregulatory.com/articles/doing-the-literature-review-for-clinical-evaluation-reports-for-software-as-a-medical-device): [plain text](https://openregulatory.com/articles/doing-the-literature-review-for-clinical-evaluation-reports-for-software-as-a-medical-device.text)
- [FDA Risk Classification for Software as a Medical Device (SaMD)](https://openregulatory.com/articles/fda-risk-classification-for-software-as-a-medical-device-samd): [plain text](https://openregulatory.com/articles/fda-risk-classification-for-software-as-a-medical-device-samd.text)
- [The Medical Device Product Development Journey: A Phase-by-Phase Guide](https://openregulatory.com/articles/the-medical-device-product-development-journey-a-phase-by-phase-guide): [plain text](https://openregulatory.com/articles/the-medical-device-product-development-journey-a-phase-by-phase-guide.text)
- [Design History File (DHF) for SaMD: Your Software's Design Story](https://openregulatory.com/articles/design-history-file-dhf-for-samd-your-software-s-design-story): [plain text](https://openregulatory.com/articles/design-history-file-dhf-for-samd-your-software-s-design-story.text)
- [Creating Turtle Diagrams for MDR & FDA Compliance](https://openregulatory.com/articles/creating-turtle-diagrams-for-mdr-amp-fda-compliance): [plain text](https://openregulatory.com/articles/creating-turtle-diagrams-for-mdr-amp-fda-compliance.text)
- [Electronic Case Report Form - FDA vs. MDR](https://openregulatory.com/articles/electronic-case-report-form-fda-amp-mdr): [plain text](https://openregulatory.com/articles/electronic-case-report-form-fda-amp-mdr.text)
- [The MDR Is Fundamentally Broken - Our Feedback To The EU](https://openregulatory.com/articles/the-mdr-is-fundamentally-broken-our-feedback-to-the-eu): [plain text](https://openregulatory.com/articles/the-mdr-is-fundamentally-broken-our-feedback-to-the-eu.text)
- [SimplerQMS Pricing: Starts At $1,200](https://openregulatory.com/articles/simplerqms-pricing): [plain text](https://openregulatory.com/articles/simplerqms-pricing.text)
- [eQMS Data Models: Hard-Coded Entities vs. Flexible Entities](https://openregulatory.com/articles/eqms-data-models-hard-coded-entities-vs-flexible-entities): [plain text](https://openregulatory.com/articles/eqms-data-models-hard-coded-entities-vs-flexible-entities.text)
- [Is Your Medical Device Safe? Understanding Biological Evaluation](https://openregulatory.com/articles/is-your-medical-device-safe-understanding-biological-evaluation): [plain text](https://openregulatory.com/articles/is-your-medical-device-safe-understanding-biological-evaluation.text)
- [Authorised Representative For Non-EU Manufacturers](https://openregulatory.com/articles/authorised-representative-for-non-eu-manufacturers): [plain text](https://openregulatory.com/articles/authorised-representative-for-non-eu-manufacturers.text)
- [The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR](https://openregulatory.com/articles/the-ultimate-comparison-iso-13485-vs-fda-21-cfr): [plain text](https://openregulatory.com/articles/the-ultimate-comparison-iso-13485-vs-fda-21-cfr.text)
- [Medical Device Codes: EMDN, UMDNS, GMDN and MDR](https://openregulatory.com/articles/medical-device-codes-emdn-umdns-gmdn-and-mdr): [plain text](https://openregulatory.com/articles/medical-device-codes-emdn-umdns-gmdn-and-mdr.text)
- [OpenRegulatory Sustainability & Governance: Will We Be Around 5 Years From Now?](https://openregulatory.com/articles/openregulatory-sustainability-governance-will-we-be-around-5-years-from-now): [plain text](https://openregulatory.com/articles/openregulatory-sustainability-governance-will-we-be-around-5-years-from-now.text)
- [FormlyAI Pricing: Not Good For Startups (2026 Update + Dovetail)](https://openregulatory.com/articles/formly-ai-pricing): [plain text](https://openregulatory.com/articles/formly-ai-pricing.text)
- [How to Document Separate Medical Device Software Components](https://openregulatory.com/articles/medical-device-software-components): [plain text](https://openregulatory.com/articles/medical-device-software-components.text)
- [QT9 Pricing: Costs, Contracts, and Uncertainties](https://openregulatory.com/articles/qt9-pricing): [plain text](https://openregulatory.com/articles/qt9-pricing.text)
- [QMS Quality Manual: Quality Policy and Quality Objectives](https://openregulatory.com/articles/qms-quality-manual-quality-policy-and-quality-objectives): [plain text](https://openregulatory.com/articles/qms-quality-manual-quality-policy-and-quality-objectives.text)
- [Matrix Requirements Got Sold: Here's What You Need To Know](https://openregulatory.com/articles/matrix-requirements-got-sold-heres-what-you-need-to-know): [plain text](https://openregulatory.com/articles/matrix-requirements-got-sold-heres-what-you-need-to-know.text)
- [Matrix Requirements Pricing: Huge Price Increase, 2026 Update](https://openregulatory.com/articles/matrix-requirements-pricing): [plain text](https://openregulatory.com/articles/matrix-requirements-pricing.text)
- [The EUDAMED Files: €9M/Year Budget and a €317K Hosting Mystery](https://openregulatory.com/articles/the-eudamed-files-e9m-year-budget-and-a-e317k-hosting-mystery): [plain text](https://openregulatory.com/articles/the-eudamed-files-e9m-year-budget-and-a-e317k-hosting-mystery.text)
- [EUDAMED: Duplicate And Missing Certificates (BEUDAMED November 2024 Update)](https://openregulatory.com/articles/eudamed-duplicate-and-missing-certificates-beudamed-november-2024-update): [plain text](https://openregulatory.com/articles/eudamed-duplicate-and-missing-certificates-beudamed-november-2024-update.text)
- [Support Us: Link To OpenRegulatory](https://openregulatory.com/articles/spread-the-word-link-to-openregulatory): [plain text](https://openregulatory.com/articles/spread-the-word-link-to-openregulatory.text)
- [How To Purchase Formwork With The Startup Discount](https://openregulatory.com/articles/how-to-purchase-formwork-with-the-startup-discount): [plain text](https://openregulatory.com/articles/how-to-purchase-formwork-with-the-startup-discount.text)
- [Greenlight Guru vs. Qualio: QMS Software Comparison](https://openregulatory.com/articles/greenlight-guru-vs-qualio): [plain text](https://openregulatory.com/articles/greenlight-guru-vs-qualio.text)
- [EUDAMED: How To Use It, And Why It Sucks](https://openregulatory.com/articles/eudamed-how-to-use-it-and-why-it-sucks): [plain text](https://openregulatory.com/articles/eudamed-how-to-use-it-and-why-it-sucks.text)
- [Medical Device Accessories](https://openregulatory.com/articles/medical-device-accessories): [plain text](https://openregulatory.com/articles/medical-device-accessories.text)
- [How To Do Formative Usability Testing For Medical Devices](https://openregulatory.com/articles/how-to-do-formative-usability-testing-for-medical-devices): [plain text](https://openregulatory.com/articles/how-to-do-formative-usability-testing-for-medical-devices.text)
- [Dot Compliance Price (QMS Software)](https://openregulatory.com/articles/dot-compliance-price): [plain text](https://openregulatory.com/articles/dot-compliance-price.text)
- [BEUDAMED: Better EUDAMED](https://openregulatory.com/articles/beudamed-better-eudamed): [plain text](https://openregulatory.com/articles/beudamed-better-eudamed.text)
- [Software (And Hardware) Test Runs in Formwork](https://openregulatory.com/articles/software-and-hardware-test-runs-in-formwork): [plain text](https://openregulatory.com/articles/software-and-hardware-test-runs-in-formwork.text)
- [Software (And Hardware) Tests In Formwork](https://openregulatory.com/articles/software-and-hardware-tests-in-formwork): [plain text](https://openregulatory.com/articles/software-and-hardware-tests-in-formwork.text)
- [Software Requirements (And Design Inputs) In Formwork](https://openregulatory.com/articles/software-requirements-and-design-inputs-in-formwork): [plain text](https://openregulatory.com/articles/software-requirements-and-design-inputs-in-formwork.text)
- [The Formwork Manual](https://openregulatory.com/articles/formwork-documentation): [plain text](https://openregulatory.com/articles/formwork-documentation.text)
- [Creating QMS Records in Formwork](https://openregulatory.com/articles/creating-qms-records-in-formwork): [plain text](https://openregulatory.com/articles/creating-qms-records-in-formwork.text)
- [Thanks For Booking Your Free Consulting Call!](https://openregulatory.com/articles/thanks-for-booking-your-free-consulting-call): [plain text](https://openregulatory.com/articles/thanks-for-booking-your-free-consulting-call.text)
- [Formwork eQMS Pricing, And When You Should Upgrade](https://openregulatory.com/articles/formwork-eqms-pricing-and-when-you-should-upgrade): [plain text](https://openregulatory.com/articles/formwork-eqms-pricing-and-when-you-should-upgrade.text)
- [Documenting Your Medical Device In Formwork](https://openregulatory.com/articles/documenting-your-medical-device-in-formwork): [plain text](https://openregulatory.com/articles/documenting-your-medical-device-in-formwork.text)
- [IVDR Requirements: What You Need To Become Compliant](https://openregulatory.com/articles/ivdr-requirements-what-you-need-to-become-compliant): [plain text](https://openregulatory.com/articles/ivdr-requirements-what-you-need-to-become-compliant.text)
- [Reviewer Roles In Formwork](https://openregulatory.com/articles/reviewer-roles-in-formwork): [plain text](https://openregulatory.com/articles/reviewer-roles-in-formwork.text)
- [Creating QMS Documents In Formwork](https://openregulatory.com/articles/creating-qms-documents-in-formwork): [plain text](https://openregulatory.com/articles/creating-qms-documents-in-formwork.text)
- [Managing Your QMS In Formwork](https://openregulatory.com/articles/managing-your-qms-in-formwork): [plain text](https://openregulatory.com/articles/managing-your-qms-in-formwork.text)
- [Video Courses In Formwork](https://openregulatory.com/articles/video-courses-in-formwork): [plain text](https://openregulatory.com/articles/video-courses-in-formwork.text)
- [Getting Started With Formwork](https://openregulatory.com/articles/getting-started-with-formwork): [plain text](https://openregulatory.com/articles/getting-started-with-formwork.text)
- [How Do We Ensure the Post-Market Surveillance Under the IVDR?](https://openregulatory.com/articles/how-do-we-ensure-the-post-market-surveillance-under-the-ivdr): [plain text](https://openregulatory.com/articles/how-do-we-ensure-the-post-market-surveillance-under-the-ivdr.text)
- [Thanks For Booking Your Formwork Demo Call!](https://openregulatory.com/articles/thanks-for-booking-your-formwork-demo-call): [plain text](https://openregulatory.com/articles/thanks-for-booking-your-formwork-demo-call.text)
- [Thanks For Booking Your Call!](https://openregulatory.com/articles/thanks-for-booking-your-call): [plain text](https://openregulatory.com/articles/thanks-for-booking-your-call.text)
- [Clinical Evidence for In-Vitro Diagnostic Medical Devices](https://openregulatory.com/articles/clinical-evidence-for-in-vitro-diagnostic-medical-devices): [plain text](https://openregulatory.com/articles/clinical-evidence-for-in-vitro-diagnostic-medical-devices.text)
- [MDR UDI: What It Is And How To Get It At GS1 Or IFA](https://openregulatory.com/articles/mdr-udi-what-it-is-and-how-to-get-it-at-gs1-or-ifa): [plain text](https://openregulatory.com/articles/mdr-udi-what-it-is-and-how-to-get-it-at-gs1-or-ifa.text)
- [The BfArM Processed Our Classification Request, And It Only Took 462 Days](https://openregulatory.com/articles/the-bfarm-processed-our-classification-request-and-it-only-took-462-days): [plain text](https://openregulatory.com/articles/the-bfarm-processed-our-classification-request-and-it-only-took-462-days.text)
- [MDR Class I: Everything You Need To Know](https://openregulatory.com/articles/mdr-class-i-everything-you-need-to-know): [plain text](https://openregulatory.com/articles/mdr-class-i-everything-you-need-to-know.text)
- [One of those Bugs a Software Engineer lives for](https://openregulatory.com/articles/bug-to-live-for): [plain text](https://openregulatory.com/articles/bug-to-live-for.text)
- [You Want To Request Another Free Template? The Answer Is No.](https://openregulatory.com/articles/you-want-to-request-another-free-template-the-answer-is-no): [plain text](https://openregulatory.com/articles/you-want-to-request-another-free-template-the-answer-is-no.text)
- [IVDR Classification: Classification Of In-Vitro Diagnostic Devices](https://openregulatory.com/articles/ivdr-classification-classification-of-in-vitro-diagnostic-devices): [plain text](https://openregulatory.com/articles/ivdr-classification-classification-of-in-vitro-diagnostic-devices.text)
- [We're Collaborating With BerlinCert, a Software-Focused Notified Body](https://openregulatory.com/articles/were-collaborating-with-berlincert-a-software-focused-notified-body): [plain text](https://openregulatory.com/articles/were-collaborating-with-berlincert-a-software-focused-notified-body.text)
- [Software Validation: How To Do It (Pain From Hell)](https://openregulatory.com/articles/software-validation-how-to-do-it-pain-from-hell): [plain text](https://openregulatory.com/articles/software-validation-how-to-do-it-pain-from-hell.text)
- [Qualio Price: What We Know So Far](https://openregulatory.com/articles/qualio-price): [plain text](https://openregulatory.com/articles/qualio-price.text)
- [Greenlight Guru Price: Crazy increase (12/2025 update)](https://openregulatory.com/articles/greenlight-guru-price): [plain text](https://openregulatory.com/articles/greenlight-guru-price.text)
- [Qualio Alternative: Don't Make This Mistake](https://openregulatory.com/articles/qualio-alternative): [plain text](https://openregulatory.com/articles/qualio-alternative.text)
- [Greenlight Guru Alternative: Enterprise Software Mistake?](https://openregulatory.com/articles/greenlight-guru-alternative): [plain text](https://openregulatory.com/articles/greenlight-guru-alternative.text)
- [IEC 62304 PDF Download](https://openregulatory.com/articles/iec-62304-pdf-download): [plain text](https://openregulatory.com/articles/iec-62304-pdf-download.text)
- [IEC 62366 PDF Download](https://openregulatory.com/articles/iec-62366-pdf-download): [plain text](https://openregulatory.com/articles/iec-62366-pdf-download.text)
- [ISO 14971 PDF Download](https://openregulatory.com/articles/iso-14971-pdf-download): [plain text](https://openregulatory.com/articles/iso-14971-pdf-download.text)
- [ISO 13485 PDF Download](https://openregulatory.com/articles/iso-13485-pdf-download): [plain text](https://openregulatory.com/articles/iso-13485-pdf-download.text)
- [Where Using ChatGPT For Regulatory Documentation Will Fail](https://openregulatory.com/articles/where-using-chatgpt-for-regulatory-documentation-will-fail): [plain text](https://openregulatory.com/articles/where-using-chatgpt-for-regulatory-documentation-will-fail.text)
- [All You Need to Know About QMS Software](https://openregulatory.com/articles/all-you-need-to-know-about-qms-software-and-eqms-software): [plain text](https://openregulatory.com/articles/all-you-need-to-know-about-qms-software-and-eqms-software.text)
- [Launching Formwork Starter: 49€ For QMS Software And Requirements Management](https://openregulatory.com/articles/launching-formwork-starter): [plain text](https://openregulatory.com/articles/launching-formwork-starter.text)
- [The Emergence Of Premium Notified Bodies: 100k€+ For Certifications](https://openregulatory.com/articles/premium-notified-bodies-100keur-certification-medical-device-regulation): [plain text](https://openregulatory.com/articles/premium-notified-bodies-100keur-certification-medical-device-regulation.text)
- [Post-Market Surveillance: The Ultimate Guide under MDR](https://openregulatory.com/articles/mdr-post-market-surveillance-ultimate-guide): [plain text](https://openregulatory.com/articles/mdr-post-market-surveillance-ultimate-guide.text)
- [Unlocking Market Access: Navigating Reimbursement Challenges for Medical Device Startups in Europe](https://openregulatory.com/articles/market-access-reimbursement-challenges-medical-device-startups-europe): [plain text](https://openregulatory.com/articles/market-access-reimbursement-challenges-medical-device-startups-europe.text)
- [The True Shadiness Of QMS Software For Medical Devices](https://openregulatory.com/articles/shadiness-qms-software-medical-devices): [plain text](https://openregulatory.com/articles/shadiness-qms-software-medical-devices.text)
- [QMS Software for Medical Devices (ISO 13485): Comparison](https://openregulatory.com/articles/qms-software-iso-13485-comparison): [plain text](https://openregulatory.com/articles/qms-software-iso-13485-comparison.text)
- [How MDD Devices Die: Two Case Studies From The Real World](https://openregulatory.com/articles/how-mdd-devices-die-two-case-studies): [plain text](https://openregulatory.com/articles/how-mdd-devices-die-two-case-studies.text)
- [No, Telemedicine Software Is Not Class IIa Under The MDR](https://openregulatory.com/articles/telemedicine-software-mdr-class-iia-hamburg): [plain text](https://openregulatory.com/articles/telemedicine-software-mdr-class-iia-hamburg.text)
- [Free QMS Software: Google Drive, SharePoint, GitHub, GitLab](https://openregulatory.com/articles/free-qms-software): [plain text](https://openregulatory.com/articles/free-qms-software.text)
- [ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes](https://openregulatory.com/articles/iso-13485-kpis-example-key-performance-indicators-for-iso-13485-processes): [plain text](https://openregulatory.com/articles/iso-13485-kpis-example-key-performance-indicators-for-iso-13485-processes.text)
- [We're Making Medical Device Compliance 10x Cheaper](https://openregulatory.com/articles/medical-device-compliance-10x-cheaper-consulting-as-a-service): [plain text](https://openregulatory.com/articles/medical-device-compliance-10x-cheaper-consulting-as-a-service.text)
- [Wise Business Is Great, Unless You Need Access To Your Money: Our Experience](https://openregulatory.com/articles/wise-business-experience-verification): [plain text](https://openregulatory.com/articles/wise-business-experience-verification.text)
- [MDR Examples: Classification Examples for EU MDR Devices](https://openregulatory.com/articles/eu-mdr-classification-examples): [plain text](https://openregulatory.com/articles/eu-mdr-classification-examples.text)
- [List of Controversial Auditor Opinions](https://openregulatory.com/articles/list-of-controversial-medical-device-auditor-opinions): [plain text](https://openregulatory.com/articles/list-of-controversial-medical-device-auditor-opinions.text)
- [IFA UDI Hack: Save Money By Using a Health Product Code (HPC)](https://openregulatory.com/articles/ifa-udi-hack-introducing-hpc-to-save-money): [plain text](https://openregulatory.com/articles/ifa-udi-hack-introducing-hpc-to-save-money.text)
- [Brace for Impact: The New MDR Transition Periods](https://openregulatory.com/articles/new-mdr-transition-periods-2023): [plain text](https://openregulatory.com/articles/new-mdr-transition-periods-2023.text)
- [Time Zones in Rails](https://openregulatory.com/articles/time-zones-in-rails-2023): [plain text](https://openregulatory.com/articles/time-zones-in-rails-2023.text)
- [Automating Medical Device Compliance With QMS Software: Can you eQMS the pain away?](https://openregulatory.com/articles/automating-medical-device-compliance-with-qms-software): [plain text](https://openregulatory.com/articles/automating-medical-device-compliance-with-qms-software.text)
- [Clinical Evaluation](https://openregulatory.com/articles/clinical-evaluation): [plain text](https://openregulatory.com/articles/clinical-evaluation.text)
- [July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software](https://openregulatory.com/articles/july-2023-updates): [plain text](https://openregulatory.com/articles/july-2023-updates.text)
- [Open Source QMS Software Overview: GitLab As QMS?](https://openregulatory.com/articles/open-source-qms-software): [plain text](https://openregulatory.com/articles/open-source-qms-software.text)
- [Supplier Management Under ISO 13485:2016](https://openregulatory.com/articles/supplier-management-iso-13485): [plain text](https://openregulatory.com/articles/supplier-management-iso-13485.text)
- [Maybe Harmonized Standards Are Becoming Freely Available Soon](https://openregulatory.com/articles/maybe-eu-standards-are-becoming-freely-available-soon): [plain text](https://openregulatory.com/articles/maybe-eu-standards-are-becoming-freely-available-soon.text)
- [How To Do a Summative Usability Testing For IEC 62366 Compliance](https://openregulatory.com/articles/how-to-do-summative-usability-evaluation-iec-62366): [plain text](https://openregulatory.com/articles/how-to-do-summative-usability-evaluation-iec-62366.text)
- [The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)](https://openregulatory.com/articles/iec-62366-usability-summary): [plain text](https://openregulatory.com/articles/iec-62366-usability-summary.text)
- [People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants](https://openregulatory.com/articles/person-responsible-for-regulatory-compliance-safety-officer-medical-device-consultant): [plain text](https://openregulatory.com/articles/person-responsible-for-regulatory-compliance-safety-officer-medical-device-consultant.text)
- [MDD Class I: Here's What You Have to Do Before May 2021](https://openregulatory.com/articles/mdd-class-i-what-to-do-before-may-2021): [plain text](https://openregulatory.com/articles/mdd-class-i-what-to-do-before-may-2021.text)
- [Do We Need a Call?](https://openregulatory.com/articles/do-we-need-a-call): [plain text](https://openregulatory.com/articles/do-we-need-a-call.text)
- [Before Our Call: Frequently Asked Questions](https://openregulatory.com/articles/before-our-call): [plain text](https://openregulatory.com/articles/before-our-call.text)
- [How We Keep Your Formwork Data Safe](https://openregulatory.com/articles/formwork-data-safety): [plain text](https://openregulatory.com/articles/formwork-data-safety.text)
- [Is Formwork an Enterprise Software? Does It Have [Enterprise Feature X]?](https://openregulatory.com/articles/is-formwork-enterprise-eqms-software): [plain text](https://openregulatory.com/articles/is-formwork-enterprise-eqms-software.text)
- [Setting Up a Quality Management System (QMS) in Google Drive](https://openregulatory.com/articles/quality-management-system-qms-in-google-drive): [plain text](https://openregulatory.com/articles/quality-management-system-qms-in-google-drive.text)
- [Clinical Evaluation: How to Write a Regulatory Compliant Literature Review](https://openregulatory.com/articles/clinical-evaluation-literature-review): [plain text](https://openregulatory.com/articles/clinical-evaluation-literature-review.text)
- [GitHub QMS: We No Longer Recommend It](https://openregulatory.com/articles/we-no-longer-recommend-github-gitlab-as-qms-software): [plain text](https://openregulatory.com/articles/we-no-longer-recommend-github-gitlab-as-qms-software.text)
- [Enterprise QMS Software: Don't Waste Your Money](https://openregulatory.com/articles/enterprise-qms-software-dont-waste-your-money): [plain text](https://openregulatory.com/articles/enterprise-qms-software-dont-waste-your-money.text)
- [Medical Device Translation: 3 Steps For Medical Device Software](https://openregulatory.com/articles/medical-device-translations-software-medical-device-samd): [plain text](https://openregulatory.com/articles/medical-device-translations-software-medical-device-samd.text)
- [How to Get a UDI (Unique Device Identifier) For MDR Compliance](https://openregulatory.com/articles/get-unique-device-identifier-udi-mdr-compliance): [plain text](https://openregulatory.com/articles/get-unique-device-identifier-udi-mdr-compliance.text)
- [What Is QMS Software, and Do You Need It?](https://openregulatory.com/articles/what-is-qms-software-and-do-you-need-it): [plain text](https://openregulatory.com/articles/what-is-qms-software-and-do-you-need-it.text)
- [FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)](https://openregulatory.com/articles/fmea-risk-acceptance-matrix-iso-14971): [plain text](https://openregulatory.com/articles/fmea-risk-acceptance-matrix-iso-14971.text)
- [ISO 14971 Walkthrough](https://openregulatory.com/articles/iso-14971-walkthrough): [plain text](https://openregulatory.com/articles/iso-14971-walkthrough.text)
- [Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps](https://openregulatory.com/articles/clinical-evaluation-report-medical-devices): [plain text](https://openregulatory.com/articles/clinical-evaluation-report-medical-devices.text)
- [DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?](https://openregulatory.com/articles/telekom-cloud-chinese-software-huawei-gdpr): [plain text](https://openregulatory.com/articles/telekom-cloud-chinese-software-huawei-gdpr.text)
- [Doing a Software Release in Compliance With IEC 62304](https://openregulatory.com/articles/software-release-iec-62304): [plain text](https://openregulatory.com/articles/software-release-iec-62304.text)
- [Software System Testing Based on the IEC 62304](https://openregulatory.com/articles/software-system-testing-iec-62304): [plain text](https://openregulatory.com/articles/software-system-testing-iec-62304.text)
- [Medical Device Software Architecture Documentation (IEC 62304)](https://openregulatory.com/articles/medical-device-software-architecture-documentation-iec-62304): [plain text](https://openregulatory.com/articles/medical-device-software-architecture-documentation-iec-62304.text)
- [Writing An Intended Use for Software as a Medical Device](https://openregulatory.com/articles/intended-use-software-medical-device): [plain text](https://openregulatory.com/articles/intended-use-software-medical-device.text)
- [Software Verification For Medical Device Software (IEC 62304)](https://openregulatory.com/articles/software-verification-medical-software-iec-62304): [plain text](https://openregulatory.com/articles/software-verification-medical-software-iec-62304.text)
- [Getting The ISO 13485 And Other Standards For Less Than 30€](https://openregulatory.com/articles/accessing-standards): [plain text](https://openregulatory.com/articles/accessing-standards.text)
- [How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)](https://openregulatory.com/articles/mdcg-2021-24-examples-for-software-classification-of-software-as-a-medical-device-samd): [plain text](https://openregulatory.com/articles/mdcg-2021-24-examples-for-software-classification-of-software-as-a-medical-device-samd.text)
- [Setting Up a Quality Management System (QMS) in GitHub / GitLab](https://openregulatory.com/articles/quality-management-system-qms-in-github-gitlab): [plain text](https://openregulatory.com/articles/quality-management-system-qms-in-github-gitlab.text)
- [Choosing a Notified Body](https://openregulatory.com/articles/choosing-notified-body): [plain text](https://openregulatory.com/articles/choosing-notified-body.text)
- [Medical Device Classification](https://openregulatory.com/articles/medical-device-classification): [plain text](https://openregulatory.com/articles/medical-device-classification.text)
- [100.000€ Spent and Never Done (Fail)](https://openregulatory.com/articles/failure-100k-spent-never-done): [plain text](https://openregulatory.com/articles/failure-100k-spent-never-done.text)
- [Writing Software Requirements Based on the IEC 62304](https://openregulatory.com/articles/software-requirements-iec-62304): [plain text](https://openregulatory.com/articles/software-requirements-iec-62304.text)
- [Writing Technical Documentation](https://openregulatory.com/articles/writing-technical-documentation): [plain text](https://openregulatory.com/articles/writing-technical-documentation.text)
- [Writing a Software Development and Maintenance Plan for IEC 62304 Compliance](https://openregulatory.com/articles/writing-software-development-maintenance-plan-iec-62304-compliance): [plain text](https://openregulatory.com/articles/writing-software-development-maintenance-plan-iec-62304-compliance.text)
- [Four Problems For DiGA Companies In The Future](https://openregulatory.com/articles/four-problems-for-diga-companies-in-the-future): [plain text](https://openregulatory.com/articles/four-problems-for-diga-companies-in-the-future.text)
- [IEC 62304 Walkthrough](https://openregulatory.com/articles/iec-62304-walkthrough): [plain text](https://openregulatory.com/articles/iec-62304-walkthrough.text)
- [Don't Hire Senior Regulatory Affairs People](https://openregulatory.com/articles/dont-hire-senior-regulatory-affairs-people): [plain text](https://openregulatory.com/articles/dont-hire-senior-regulatory-affairs-people.text)
- [The MDR Class I Software Situation](https://openregulatory.com/articles/mdr-class-i-software-situation): [plain text](https://openregulatory.com/articles/mdr-class-i-software-situation.text)
- [CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?](https://openregulatory.com/articles/capa-corrective-and-preventive-action-iso-13485): [plain text](https://openregulatory.com/articles/capa-corrective-and-preventive-action-iso-13485.text)
- [ISO 13485](https://openregulatory.com/articles/iso-13485): [plain text](https://openregulatory.com/articles/iso-13485.text)
- [IEC 62366](https://openregulatory.com/articles/iec-62366): [plain text](https://openregulatory.com/articles/iec-62366.text)
- [IEC 62304](https://openregulatory.com/articles/iec-62304): [plain text](https://openregulatory.com/articles/iec-62304.text)
- [ISO 14971](https://openregulatory.com/articles/iso-14971): [plain text](https://openregulatory.com/articles/iso-14971.text)
- [We Got Audited By a Competent Authority. Here's What You Need To Know.](https://openregulatory.com/articles/mdr-competent-authority-lageso-audit-what-you-need-to-know): [plain text](https://openregulatory.com/articles/mdr-competent-authority-lageso-audit-what-you-need-to-know.text)
- [We're Sending Out Honest Rejections Now](https://openregulatory.com/articles/honest-rejections): [plain text](https://openregulatory.com/articles/honest-rejections.text)
- [Generate Your Technical Documentation Automatically: Formwork Audit Export](https://openregulatory.com/articles/formwork-generate-technical-documentation-automatically-audit-export): [plain text](https://openregulatory.com/articles/formwork-generate-technical-documentation-automatically-audit-export.text)
- [Using Formwork as a Regulatory Consultant](https://openregulatory.com/articles/formwork-qms-software-for-regulatory-consultants): [plain text](https://openregulatory.com/articles/formwork-qms-software-for-regulatory-consultants.text)
- [Copying Records is Tedious.. Not Anymore!](https://openregulatory.com/articles/formwork-qms-software-copying-records-for-techdoc-release): [plain text](https://openregulatory.com/articles/formwork-qms-software-copying-records-for-techdoc-release.text)
- [No Lock-In, Ever: Formwork Batch Export](https://openregulatory.com/articles/formwork-batch-export-no-qms-software-vendor-lock-in): [plain text](https://openregulatory.com/articles/formwork-batch-export-no-qms-software-vendor-lock-in.text)
- [We're Launching Free Consulting](https://openregulatory.com/articles/were-launching-free-consulting): [plain text](https://openregulatory.com/articles/were-launching-free-consulting.text)
- [The Great Notified Body Survey](https://openregulatory.com/articles/the-great-notified-body-survey-2022): [plain text](https://openregulatory.com/articles/the-great-notified-body-survey-2022.text)
- [The IVDR Might Require 264 Notified Bodies](https://openregulatory.com/articles/the-ivdr-might-require-264-notified-bodies): [plain text](https://openregulatory.com/articles/the-ivdr-might-require-264-notified-bodies.text)
- [ISO 13485 Amendment, Templates, User Manuals](https://openregulatory.com/articles/iso-13485-amendment-templates-user-manuals): [plain text](https://openregulatory.com/articles/iso-13485-amendment-templates-user-manuals.text)
- [MDR Classification Chaos and User Manuals](https://openregulatory.com/articles/mdr-classification-chaos-and-user-manuals): [plain text](https://openregulatory.com/articles/mdr-classification-chaos-and-user-manuals.text)
- [FBE GmbH: Solving Problems and Reviewing Documents For Less Than 2.000€](https://openregulatory.com/articles/fbe-gmbh-baby-care-document-review-less-than-2000-eur): [plain text](https://openregulatory.com/articles/fbe-gmbh-baby-care-document-review-less-than-2000-eur.text)
- [OpenRegulatory Newsletter #1: Conference](https://openregulatory.com/articles/openregulatory-newsletter-1-conference): [plain text](https://openregulatory.com/articles/openregulatory-newsletter-1-conference.text)
- [Exakt Health: MDD Class I Compliant in 3 Months](https://openregulatory.com/articles/exakt-health-mdd-class-i-compliant-3-months): [plain text](https://openregulatory.com/articles/exakt-health-mdd-class-i-compliant-3-months.text)
- [No Cookie (Consent Dialogue) For You](https://openregulatory.com/articles/no-cookie-consent-dialogue-for-you): [plain text](https://openregulatory.com/articles/no-cookie-consent-dialogue-for-you.text)
- [EU MDR: Step-By-Step Guide To Becoming Compliant](https://openregulatory.com/articles/blueprint-certifying-medical-software): [plain text](https://openregulatory.com/articles/blueprint-certifying-medical-software.text)

## Document Templates
- [Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"](https://openregulatory.com/document_templates/questionnaire-cybersecurity-for-medical-devices-technical-documentation): [plain text](https://openregulatory.com/document_templates/questionnaire-cybersecurity-for-medical-devices-technical-documentation.text)
- [ISO 14971:2019 Mapping of Requirements to Documents](https://openregulatory.com/document_templates/iso-149712019-mapping-of-requirements-to-documents): [plain text](https://openregulatory.com/document_templates/iso-149712019-mapping-of-requirements-to-documents.text)
- [SOP Information Security Risk Assessment](https://openregulatory.com/document_templates/sop-information-security-risk-assessment): [plain text](https://openregulatory.com/document_templates/sop-information-security-risk-assessment.text)
- [Information Security Policy And Scope](https://openregulatory.com/document_templates/information-security-policy-and-scope): [plain text](https://openregulatory.com/document_templates/information-security-policy-and-scope.text)
- [Information Security Controls](https://openregulatory.com/document_templates/information-security-controls): [plain text](https://openregulatory.com/document_templates/information-security-controls.text)
- [ISO 27001:2023 Mapping of Requirements to Documents](https://openregulatory.com/document_templates/iso-270012023-mapping-of-requirements-to-documents): [plain text](https://openregulatory.com/document_templates/iso-270012023-mapping-of-requirements-to-documents.text)
- [SOP Purchasing](https://openregulatory.com/document_templates/sop-purchasing): [plain text](https://openregulatory.com/document_templates/sop-purchasing.text)
- [MDR Declaration of Conformity](https://openregulatory.com/document_templates/mdr-declaration-of-conformity): [plain text](https://openregulatory.com/document_templates/mdr-declaration-of-conformity.text)
- [MDR Classification Document](https://openregulatory.com/document_templates/mdr-classification-document): [plain text](https://openregulatory.com/document_templates/mdr-classification-document.text)
- [Internal Audit Report](https://openregulatory.com/document_templates/internal-audit-report): [plain text](https://openregulatory.com/document_templates/internal-audit-report.text)
- [Literature Evaluation Table (MDR Clinical Evaluation)](https://openregulatory.com/document_templates/literature-evaluation-table-mdr-clinical-evaluation): [plain text](https://openregulatory.com/document_templates/literature-evaluation-table-mdr-clinical-evaluation.text)
- [Instructions On Data Acquisition (Machine Learning / AI)](https://openregulatory.com/document_templates/instructions-on-data-acquisition-machine-learning-ai): [plain text](https://openregulatory.com/document_templates/instructions-on-data-acquisition-machine-learning-ai.text)
- [SOP Machine Learning Model Development (AI)](https://openregulatory.com/document_templates/sop-machine-learning-model-development-ai): [plain text](https://openregulatory.com/document_templates/sop-machine-learning-model-development-ai.text)
- [Instructions On Data Annotation (Machine Learning / AI)](https://openregulatory.com/document_templates/instructions-on-data-annotation-machine-learning-ai): [plain text](https://openregulatory.com/document_templates/instructions-on-data-annotation-machine-learning-ai.text)
- [Instructions for Use (IfU)](https://openregulatory.com/document_templates/instructions-for-use): [plain text](https://openregulatory.com/document_templates/instructions-for-use.text)
- [PRRC Appointment Letter](https://openregulatory.com/document_templates/prrc-appointment-letter): [plain text](https://openregulatory.com/document_templates/prrc-appointment-letter.text)
- [Checklist: Clinical Evaluation Report](https://openregulatory.com/document_templates/checklist-clinical-evaluation-report): [plain text](https://openregulatory.com/document_templates/checklist-clinical-evaluation-report.text)
- [Risk Management Plan](https://openregulatory.com/document_templates/risk-management-plan-and-risk-acceptance-matrix): [plain text](https://openregulatory.com/document_templates/risk-management-plan-and-risk-acceptance-matrix.text)
- [Quality Manual, Policy, Objectives](https://openregulatory.com/document_templates/quality-manual-policy-objectives): [plain text](https://openregulatory.com/document_templates/quality-manual-policy-objectives.text)
- [List of Known Anomalies](https://openregulatory.com/document_templates/list-of-known-anomalies): [plain text](https://openregulatory.com/document_templates/list-of-known-anomalies.text)
- [SOP Software Validation](https://openregulatory.com/document_templates/sop-software-validation): [plain text](https://openregulatory.com/document_templates/sop-software-validation.text)
- [SOP Vigilance](https://openregulatory.com/document_templates/sop-vigilance): [plain text](https://openregulatory.com/document_templates/sop-vigilance.text)
- [Post-Market Surveillance Plan](https://openregulatory.com/document_templates/post-market-surveillance-plan): [plain text](https://openregulatory.com/document_templates/post-market-surveillance-plan.text)
- [SOP Corrective and Preventive Action (CAPA)](https://openregulatory.com/document_templates/sop-corrective-and-preventive-action-capa): [plain text](https://openregulatory.com/document_templates/sop-corrective-and-preventive-action-capa.text)
- [Incident Assessment Form](https://openregulatory.com/document_templates/incident-assessment-form): [plain text](https://openregulatory.com/document_templates/incident-assessment-form.text)
- [SOP Post-Market Surveillance](https://openregulatory.com/document_templates/sop-post-market-surveillance): [plain text](https://openregulatory.com/document_templates/sop-post-market-surveillance.text)
- [SOP Feedback Management and Customer Complaints](https://openregulatory.com/document_templates/sop-feedback-management-and-customer-complaints): [plain text](https://openregulatory.com/document_templates/sop-feedback-management-and-customer-complaints.text)
- [SOP Software Problem Resolution](https://openregulatory.com/document_templates/sop-software-problem-resolution): [plain text](https://openregulatory.com/document_templates/sop-software-problem-resolution.text)
- [SOP Integrated Software Development](https://openregulatory.com/document_templates/sop-integrated-software-development): [plain text](https://openregulatory.com/document_templates/sop-integrated-software-development.text)
- [SOP Update of Regulations](https://openregulatory.com/document_templates/sop-update-of-regulations): [plain text](https://openregulatory.com/document_templates/sop-update-of-regulations.text)
- [Post-Market Clinical Follow-Up Plan (PMCFP)](https://openregulatory.com/document_templates/post-market-clinical-follow-up-plan-pmcfp): [plain text](https://openregulatory.com/document_templates/post-market-clinical-follow-up-plan-pmcfp.text)
- [Post-Market Clinical Follow-Up Report (PMCFR)](https://openregulatory.com/document_templates/post-market-clinical-follow-up-report-pmcfr): [plain text](https://openregulatory.com/document_templates/post-market-clinical-follow-up-report-pmcfr.text)
- [List of Medical Devices](https://openregulatory.com/document_templates/list-of-medical-devices): [plain text](https://openregulatory.com/document_templates/list-of-medical-devices.text)
- [Checklist: User Needs Review](https://openregulatory.com/document_templates/checklist-user-needs-review): [plain text](https://openregulatory.com/document_templates/checklist-user-needs-review.text)
- [Supplier Checklist](https://openregulatory.com/document_templates/supplier-checklist): [plain text](https://openregulatory.com/document_templates/supplier-checklist.text)
- [Software Development and Maintenance Plan](https://openregulatory.com/document_templates/software-development-and-maintenance-plan): [plain text](https://openregulatory.com/document_templates/software-development-and-maintenance-plan.text)
- [SOP Management Review](https://openregulatory.com/document_templates/sop-management-review): [plain text](https://openregulatory.com/document_templates/sop-management-review.text)
- [SOP Product Certification and Registration](https://openregulatory.com/document_templates/sop-product-certification-and-registration): [plain text](https://openregulatory.com/document_templates/sop-product-certification-and-registration.text)
- [Internal Audit Program](https://openregulatory.com/document_templates/internal-audit-program): [plain text](https://openregulatory.com/document_templates/internal-audit-program.text)
- [Internal Audit Plan](https://openregulatory.com/document_templates/internal-audit-plan): [plain text](https://openregulatory.com/document_templates/internal-audit-plan.text)
- [Intended Use (for Medical Devices Under MDD / MDR)](https://openregulatory.com/document_templates/intended-use-for-medical-devices-under-mdd-mdr): [plain text](https://openregulatory.com/document_templates/intended-use-for-medical-devices-under-mdd-mdr.text)
- [Change Evaluation List](https://openregulatory.com/document_templates/change-evaluation-list): [plain text](https://openregulatory.com/document_templates/change-evaluation-list.text)
- [SOP Clinical Evaluation](https://openregulatory.com/document_templates/sop-clinical-evaluation): [plain text](https://openregulatory.com/document_templates/sop-clinical-evaluation.text)
- [Checklist: MDR General Safety and Performance Requirements](https://openregulatory.com/document_templates/checklist-mdr-general-safety-and-performance-requirements): [plain text](https://openregulatory.com/document_templates/checklist-mdr-general-safety-and-performance-requirements.text)
- [SOP Change Management](https://openregulatory.com/document_templates/sop-change-management): [plain text](https://openregulatory.com/document_templates/sop-change-management.text)
- [List of Regulatory Requirements](https://openregulatory.com/document_templates/list-of-regulatory-requirements): [plain text](https://openregulatory.com/document_templates/list-of-regulatory-requirements.text)
- [SOP Document and Record Control](https://openregulatory.com/document_templates/sop-document-and-record-control): [plain text](https://openregulatory.com/document_templates/sop-document-and-record-control.text)
- [SOP Sales](https://openregulatory.com/document_templates/sop-sales): [plain text](https://openregulatory.com/document_templates/sop-sales.text)
- [SOP Human Resources Administration](https://openregulatory.com/document_templates/sop-human-resources-administration): [plain text](https://openregulatory.com/document_templates/sop-human-resources-administration.text)
- [Periodic Safety Update Report](https://openregulatory.com/document_templates/periodic-safety-update-report): [plain text](https://openregulatory.com/document_templates/periodic-safety-update-report.text)
- [Clinical Evaluation Plan](https://openregulatory.com/document_templates/clinical-evaluation-plan): [plain text](https://openregulatory.com/document_templates/clinical-evaluation-plan.text)
- [Usability Evaluation Plan](https://openregulatory.com/document_templates/usability-evaluation-plan): [plain text](https://openregulatory.com/document_templates/usability-evaluation-plan.text)
- [Clinical Evaluation Report](https://openregulatory.com/document_templates/clinical-evaluation-report): [plain text](https://openregulatory.com/document_templates/clinical-evaluation-report.text)
- [Document Roadmap for Technical Documentation](https://openregulatory.com/document_templates/document-roadmap-for-technical-documentation): [plain text](https://openregulatory.com/document_templates/document-roadmap-for-technical-documentation.text)
- [ISO 13485: Mapping of Requirements to Documents](https://openregulatory.com/document_templates/iso-13485-mapping-of-requirements-to-documents): [plain text](https://openregulatory.com/document_templates/iso-13485-mapping-of-requirements-to-documents.text)
- [Software Architecture Description](https://openregulatory.com/document_templates/software-architecture-description): [plain text](https://openregulatory.com/document_templates/software-architecture-description.text)
- [Software Architecture Checklist](https://openregulatory.com/document_templates/software-architecture-checklist): [plain text](https://openregulatory.com/document_templates/software-architecture-checklist.text)
- [Data Protection Statement (Privacy Policy)](https://openregulatory.com/document_templates/data-protection-statement-privacy-policy): [plain text](https://openregulatory.com/document_templates/data-protection-statement-privacy-policy.text)
- [Machine Learning Algorithm Validation Report](https://openregulatory.com/document_templates/machine-learning-algorithm-validation-report): [plain text](https://openregulatory.com/document_templates/machine-learning-algorithm-validation-report.text)
- [SOP Deployment](https://openregulatory.com/document_templates/sop-deployment): [plain text](https://openregulatory.com/document_templates/sop-deployment.text)
- [List of Medical Device Consultants](https://openregulatory.com/document_templates/list-of-medical-device-consultants): [plain text](https://openregulatory.com/document_templates/list-of-medical-device-consultants.text)
- [Employee Data Protection and Confidentiality Agreement](https://openregulatory.com/document_templates/employee-data-protection-and-confidentiality-agreement): [plain text](https://openregulatory.com/document_templates/employee-data-protection-and-confidentiality-agreement.text)
- [Technical and Organizational Measures](https://openregulatory.com/document_templates/technical-and-organizational-measures): [plain text](https://openregulatory.com/document_templates/technical-and-organizational-measures.text)
- [FMEA: Risk Table](https://openregulatory.com/document_templates/fmea-risk-table): [plain text](https://openregulatory.com/document_templates/fmea-risk-table.text)
- [User Needs List](https://openregulatory.com/document_templates/user-needs-list): [plain text](https://openregulatory.com/document_templates/user-needs-list.text)
- [Risk Management Report](https://openregulatory.com/document_templates/risk-management-report): [plain text](https://openregulatory.com/document_templates/risk-management-report.text)
- [Checklist: Software Requirements Review](https://openregulatory.com/document_templates/checklist-software-requirements-review): [plain text](https://openregulatory.com/document_templates/checklist-software-requirements-review.text)
- [IEC 62366-1:2015 Mapping of Requirements to Documents](https://openregulatory.com/document_templates/iec-62366-12015-mapping-of-requirements-to-documents): [plain text](https://openregulatory.com/document_templates/iec-62366-12015-mapping-of-requirements-to-documents.text)
- [SOUP List (Software of Unknown Provenance)](https://openregulatory.com/document_templates/soup-list-software-of-unknown-provenance): [plain text](https://openregulatory.com/document_templates/soup-list-software-of-unknown-provenance.text)
- [Checklist: Software Release](https://openregulatory.com/document_templates/checklist-software-release): [plain text](https://openregulatory.com/document_templates/checklist-software-release.text)
- [List of Hazard-Related Use Scenarios](https://openregulatory.com/document_templates/list-of-hazard-related-use-scenarios): [plain text](https://openregulatory.com/document_templates/list-of-hazard-related-use-scenarios.text)
- [Performance Evaluation Plan (IVDD)](https://openregulatory.com/document_templates/performance-evaluation-plan-ivdd): [plain text](https://openregulatory.com/document_templates/performance-evaluation-plan-ivdd.text)
- [Usability Evaluation Report](https://openregulatory.com/document_templates/usability-evaluation-report): [plain text](https://openregulatory.com/document_templates/usability-evaluation-report.text)
- [Software Requirements List](https://openregulatory.com/document_templates/software-requirements-list): [plain text](https://openregulatory.com/document_templates/software-requirements-list.text)
- [IEC 62304:2006 Mapping of Requirements to Documents](https://openregulatory.com/document_templates/iec-623042006-mapping-of-requirements-to-documents): [plain text](https://openregulatory.com/document_templates/iec-623042006-mapping-of-requirements-to-documents.text)
- [Bug Fixes Documentation List](https://openregulatory.com/document_templates/bug-fixes-documentation-list): [plain text](https://openregulatory.com/document_templates/bug-fixes-documentation-list.text)
- [Software System Test Plan](https://openregulatory.com/document_templates/software-system-test-plan): [plain text](https://openregulatory.com/document_templates/software-system-test-plan.text)
- [Software Validation Form](https://openregulatory.com/document_templates/software-validation-form): [plain text](https://openregulatory.com/document_templates/software-validation-form.text)
- [List of Qualified Suppliers](https://openregulatory.com/document_templates/list-of-qualified-suppliers): [plain text](https://openregulatory.com/document_templates/list-of-qualified-suppliers.text)
- [List of Training Documentation](https://openregulatory.com/document_templates/list-of-training-documentation): [plain text](https://openregulatory.com/document_templates/list-of-training-documentation.text)
- [Field Safety Notice](https://openregulatory.com/document_templates/field-safety-notice): [plain text](https://openregulatory.com/document_templates/field-safety-notice.text)
- [CAPA List](https://openregulatory.com/document_templates/capa-list): [plain text](https://openregulatory.com/document_templates/capa-list.text)
- [Performance Evaluation Report (IVDD)](https://openregulatory.com/document_templates/performance-evaluation-report-ivdd): [plain text](https://openregulatory.com/document_templates/performance-evaluation-report-ivdd.text)
- [MDD Essential Requirements](https://openregulatory.com/document_templates/mdd-essential-requirements-template): [plain text](https://openregulatory.com/document_templates/mdd-essential-requirements-template.text)
- [Document List QMS](https://openregulatory.com/document_templates/document-list-qms): [plain text](https://openregulatory.com/document_templates/document-list-qms.text)
- [Training Record](https://openregulatory.com/document_templates/training-record): [plain text](https://openregulatory.com/document_templates/training-record.text)
- [Usability Evaluation Protocol](https://openregulatory.com/document_templates/usability-evaluation-protocol): [plain text](https://openregulatory.com/document_templates/usability-evaluation-protocol.text)
- [Management Review Report](https://openregulatory.com/document_templates/management-review-report): [plain text](https://openregulatory.com/document_templates/management-review-report.text)
- [List of Data Processing Activities with Data Protection Impact Assessment (DPIA)](https://openregulatory.com/document_templates/list-of-data-processing-activities-with-data-protection-impact-assessment-dpia): [plain text](https://openregulatory.com/document_templates/list-of-data-processing-activities-with-data-protection-impact-assessment-dpia.text)
- [Software List](https://openregulatory.com/document_templates/software-list): [plain text](https://openregulatory.com/document_templates/software-list.text)
- [SOP Internal Audit](https://openregulatory.com/document_templates/sop-internal-audit): [plain text](https://openregulatory.com/document_templates/sop-internal-audit.text)

## Q&A
- [Trend reporting is a PMS input or output?](https://openregulatory.com/questions/trend-reporting-is-a-pms-input-or-output)
- [Is internally used diagnostic software considered a medical device under MDR?](https://openregulatory.com/questions/is-internally-used-diagnostic-software-considered-a-medical-device-under-mdr)
- [Is a US-based test dataset mandatory for FDA clearance of dental AI software?](https://openregulatory.com/questions/is-a-us-based-test-dataset-mandatory-for-fda-clearance-of-dental-ai-software)
- [How to ensure user manual readability and usability during testing?](https://openregulatory.com/questions/how-to-ensure-user-manual-readability-and-usability-during-testing)
- [Does software that analyzes EHR blood test results meet FDA CDS criterion 1?](https://openregulatory.com/questions/does-software-that-analyzes-ehr-blood-test-results-meet-fda-cds-criterion-1)
- [Are there FDA requirements for non-device clinical decision support software?](https://openregulatory.com/questions/are-there-fda-requirements-for-non-device-clinical-decision-support-software)
- [Is it appropriate to exclude ISO 13485 section 7.6 for SaMD under IVDR?](https://openregulatory.com/questions/is-it-appropriate-to-exclude-iso-13485-section-7-6-for-samd-under-ivdr)
- [UDI and EUDAMED Requirements for Legacy MDD Devices as of May 2023](https://openregulatory.com/questions/udi-and-eudamed-requirements-for-legacy-mdd-devices-as-of-may-2023)
- [FDA requirements for SBOM submission: summary, machine-readable formats, and PDF attachments](https://openregulatory.com/questions/fda-requirements-for-sbom-submission-summary-machine-readable-formats-and-pdf-attachments)
- [Examples for SOP content for Infrastructure and Work Environment in ISO 13485 QMS for software](https://openregulatory.com/questions/examples-for-sop-content-for-infrastructure-and-work-environment-in-iso-13485-qms-for-software)
- [Is the FDA planning to drop Part 11 requirements for electronic records?](https://openregulatory.com/questions/is-the-fda-planning-to-drop-part-11-requirements-for-electronic-records)
- [Why can some US-marketed health software claim disease risk without FDA medical device approval?](https://openregulatory.com/questions/why-can-some-us-marketed-health-software-claim-disease-risk-without-fda-medical-device-approval)
- [Are there equivalent classifications to FDA Class I and II viewers under EU MDR?](https://openregulatory.com/questions/are-there-equivalent-classifications-to-fda-class-i-and-ii-viewers-under-eu-mdr)
- [FDA 'General Use' Classification for Surgical Instruments Intended for Specific Procedures](https://openregulatory.com/questions/fda-general-use-classification-for-surgical-instruments-intended-for-specific-procedures)
- [How to refine and standardise data quality control requirements for medical device algorithms?](https://openregulatory.com/questions/how-to-refine-and-standardise-data-quality-control-requirements-for-medical-device-algorithms)
- [How should change control be applied to complementary software in medical device projects?](https://openregulatory.com/questions/how-should-change-control-be-applied-to-complementary-software-in-medical-device-projects)
- [Should IT administrators be included as user roles in MDR technical documentation for SaMD?](https://openregulatory.com/questions/should-it-administrators-be-included-as-user-roles-in-mdr-technical-documentation-for-samd)
- [How to prepare for MDR QMS audits by Notified Bodies?](https://openregulatory.com/questions/how-to-prepare-for-mdr-qms-audits-by-notified-bodies)
- [How can the usability of the MDR and related standards be improved for startups?](https://openregulatory.com/questions/how-can-the-usability-of-the-mdr-and-related-standards-be-improved-for-startups)
- [Is EUDAMED registration mandatory for economic operators in Germany?](https://openregulatory.com/questions/is-eudamed-registration-mandatory-for-economic-operators-in-germany)
- [Does software that provides glasses prescriptions perform a diagnosis under EU MDR?](https://openregulatory.com/questions/does-software-that-provides-glasses-prescriptions-perform-a-diagnosis-under-eu-mdr)
- [How to ensure GDPR compliance for patient data logging in a digital health clinical trial?](https://openregulatory.com/questions/how-to-ensure-gdpr-compliance-for-patient-data-logging-in-a-digital-health-clinical-trial)
- [How to convert GTIN-13 to GTIN-14 for EUDAMED UDI-DI submission?](https://openregulatory.com/questions/how-to-convert-gtin-13-to-gtin-14-for-eudamed-udi-di-submission)
- [Do distributors need to register in EUDAMED under MDR?](https://openregulatory.com/questions/do-distributors-need-to-register-in-eudamed-under-mdr)
- [Why are some devices and UDIs not listed on EUDAMED despite manufacturer registration?](https://openregulatory.com/questions/why-are-some-devices-and-udis-not-listed-on-eudamed-despite-manufacturer-registration)
- [Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?](https://openregulatory.com/questions/is-a-new-qms-audit-required-for-mdr-certification-if-we-already-have-mdd-and-iso-13485-certification)
- [How to handle incremental software changes during MDR certification?](https://openregulatory.com/questions/how-to-handle-incremental-software-changes-during-mdr-certification)
- [Recommendations for EU-compliant electronic signature systems for medical device documentation](https://openregulatory.com/questions/recommendations-for-eu-compliant-electronic-signature-systems-for-medical-device-documentation)
- [How to comply with EU 207/2012 electronic IFU requirements for medical device apps?](https://openregulatory.com/questions/how-to-comply-with-eu-207-2012-electronic-ifu-requirements-for-medical-device-apps)
- [Is EEG data considered a "specimen" under the IVDR?](https://openregulatory.com/questions/is-eeg-data-considered-a-specimen-under-the-ivdr)
- [Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?](https://openregulatory.com/questions/is-iso-13485-certification-required-before-ce-marking-for-software-medical-devices-in-the-eu-and-switzerland)
- [Are distributors required to register in EUDAMED under MDR?](https://openregulatory.com/questions/are-distributors-required-to-register-in-eudamed-under-mdr)
- [Is the EU planning to clarify regulation of continuously learning AI in medical devices?](https://openregulatory.com/questions/is-the-eu-planning-to-clarify-regulation-of-continuously-learning-ai-in-medical-devices)
- [Recommendations for EU Notified Bodies for CE and MDR applications outside Germany](https://openregulatory.com/questions/recommendations-for-eu-notified-bodies-for-ce-and-mdr-applications-outside-germany)
- [How to generate EUDAMED ID DI for MDD devices and what manufacturer device code is needed?](https://openregulatory.com/questions/how-to-generate-eudamed-id-di-for-mdd-devices-and-what-manufacturer-device-code-is-needed)
- [Can clinical evaluation for a Class I SaMD app rely on literature from similar, but not equivalent, devices?](https://openregulatory.com/questions/can-clinical-evaluation-for-a-class-i-samd-app-rely-on-literature-from-similar-but-not-equivalent-devices)
- [Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?](https://openregulatory.com/questions/are-eu-mdr-obligations-triggered-if-an-eu-manufacturer-sells-via-a-distributor-outside-the-eu)
- [Can translated instructional video text be adjusted for lip sync without affecting evidence transferability?](https://openregulatory.com/questions/can-translated-instructional-video-text-be-adjusted-for-lip-sync-without-affecting-evidence-transferability)
- [How should code editors like VS Code be validated in SaMD development?](https://openregulatory.com/questions/how-should-code-editors-like-vs-code-be-validated-in-samd-development)
- [How to register MDD devices in EUDAMED and generate EUDAMED ID/DI](https://openregulatory.com/questions/how-to-register-mdd-devices-in-eudamed-and-generate-eudamed-id-di)
- [How do you handle CAPA investigations and bug triage for SaMDs?](https://openregulatory.com/questions/how-do-you-handle-capa-investigations-and-bug-triage-for-samds)
- [Do IVDR Annex IX Chapter II certificates apply to Class C devices?](https://openregulatory.com/questions/do-ivdr-annex-ix-chapter-ii-certificates-apply-to-class-c-devices)
- [What name should appear on an IEC 60601 conformity certificate for hardware supplied by a third party?](https://openregulatory.com/questions/what-name-should-appear-on-an-iec-60601-conformity-certificate-for-hardware-supplied-by-a-third-party)
- [Experience navigating significant change notifications under MDR/IVDR for SaMD](https://openregulatory.com/questions/experience-navigating-significant-change-notifications-under-mdr-ivdr-for-samd)
- [How to handle MDR (EU) 2021/2226 Article 5.3 and 5.4 requirements for eIFU?](https://openregulatory.com/questions/how-to-handle-mdr-eu-2021-2226-article-5-3-and-5-4-requirements-for-eifu)
- [How to select the appropriate EMDN code for stand-alone medical device software?](https://openregulatory.com/questions/how-to-select-the-appropriate-emdn-code-for-stand-alone-medical-device-software)
- [Is CE marking required for internally used medical software provided as a service?](https://openregulatory.com/questions/is-ce-marking-required-for-internally-used-medical-software-provided-as-a-service)
- [How to find UMDNS and GMDN codes for SaMD?](https://openregulatory.com/questions/how-to-find-umdns-and-gmdn-codes-for-samd)
- [Does providing refractive values for glasses count as a diagnosis under MDR?](https://openregulatory.com/questions/does-providing-refractive-values-for-glasses-count-as-a-diagnosis-under-mdr)
- [How do companies handle MDR Annex III complaint investigation and market experience analysis?](https://openregulatory.com/questions/how-do-companies-handle-mdr-annex-iii-complaint-investigation-and-market-experience-analysis)
- [How do you assess and qualify SOUP suppliers, and how do you determine their criticality?](https://openregulatory.com/questions/how-do-you-assess-and-qualify-soup-suppliers-and-how-do-you-determine-their-criticality)
- [Is it sufficient to use literature data only for MDR clinical evaluation of SaMD, or is own clinical data required?](https://openregulatory.com/questions/is-it-sufficient-to-use-literature-data-only-for-mdr-clinical-evaluation-of-samd-or-is-own-clinical-data-required)
- [Difference between Annex IX and Annex XI for MDR Class IIa Technical File Review](https://openregulatory.com/questions/difference-between-annex-ix-and-annex-xi-for-mdr-class-iia-technical-file-review)
- [Do DiGA changes need to be reported to BfArM prior to implementation?](https://openregulatory.com/questions/do-diga-changes-need-to-be-reported-to-bfarm-prior-to-implementation)
- [Is UDI required for Class I devices under MDR before May 2025?](https://openregulatory.com/questions/is-udi-required-for-class-i-devices-under-mdr-before-may-2025)
- [What are the requirements for 'Authentisierung von GKV-Versicherten' for DiGAs in Germany from January 1st?](https://openregulatory.com/questions/what-are-the-requirements-for-authentisierung-von-gkv-versicherten-for-digas-in-germany-from-january-1st)
- [Using Own Device as Equivalent Device During MDD to MDR Transition](https://openregulatory.com/questions/using-own-device-as-equivalent-device-during-mdd-to-mdr-transition)
- [Is it permissible to provide access to a DiGA app before insurance approval?](https://openregulatory.com/questions/is-it-permissible-to-provide-access-to-a-diga-app-before-insurance-approval)
- [Is additional registration required in France for MDR Class I device already registered in Germany?](https://openregulatory.com/questions/is-additional-registration-required-in-france-for-mdr-class-i-device-already-registered-in-germany)
- [Is CE marking required for internally used EEG analysis software provided as a service to hospitals?](https://openregulatory.com/questions/is-ce-marking-required-for-internally-used-eeg-analysis-software-provided-as-a-service-to-hospitals)
- [Is it necessary to include device classification and intended use in every section of DHF and TD documentation?](https://openregulatory.com/questions/is-it-necessary-to-include-device-classification-and-intended-use-in-every-section-of-dhf-and-td-documentation)
- [How to demonstrate clinical equivalence for MDSW when competitor data is unavailable?](https://openregulatory.com/questions/how-to-demonstrate-clinical-equivalence-for-mdsw-when-competitor-data-is-unavailable)
- [Can a software feature be labeled as RUO or performance evaluation only within a medical device software?](https://openregulatory.com/questions/can-a-software-feature-be-labeled-as-ruo-or-performance-evaluation-only-within-a-medical-device-software)
- [Are commercial VR headsets and computers considered medical device accessories under MDR when sold as a system with SaMD?](https://openregulatory.com/questions/are-commercial-vr-headsets-and-computers-considered-medical-device-accessories-under-mdr-when-sold-as-a-system-with-samd)
- [Are amendments to the Declaration of Conformity needed for non-significant UI changes shown in screenshots?](https://openregulatory.com/questions/are-amendments-to-the-declaration-of-conformity-needed-for-non-significant-ui-changes-shown-in-screenshots)
- [Best team setup for Class I (EU) medical device QMS and technical documentation?](https://openregulatory.com/questions/best-team-setup-for-class-i-eu-medical-device-qms-and-technical-documentation)
- [Can an investigator-initiated study qualify as a PMCF study under MDR?](https://openregulatory.com/questions/can-an-investigator-initiated-study-qualify-as-a-pmcf-study-under-mdr)
- [Under what circumstances can a medical app be classified as Class I under MDR?](https://openregulatory.com/questions/under-what-circumstances-can-a-medical-app-be-classified-as-class-i-under-mdr)
- [Can the CER evaluator under EU MDR be an internal employee, and how to manage conflicts of interest?](https://openregulatory.com/questions/can-the-cer-evaluator-under-eu-mdr-be-an-internal-employee-and-how-to-manage-conflicts-of-interest)
- [What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?](https://openregulatory.com/questions/what-is-my-company-s-role-under-mdr-when-incorporating-a-ce-marked-software-medical-device-from-another-manufacturer-into-our-non-medical-app)
- [Timeline and Minimum Cost for CE Certification Class IIa Without Clinical Trial](https://openregulatory.com/questions/timeline-and-minimum-cost-for-ce-certification-class-iia-without-clinical-trial)
- [SaMD : Is the frontend part of the medicla device under EU MDR ?](https://openregulatory.com/questions/samd-is-the-frontend-part-of-the-medicla-device-under-eu-mdr)
- [How to handle identification and validity of electronic controlled documents under ISO 13485?](https://openregulatory.com/questions/how-to-handle-identification-and-validity-of-electronic-controlled-documents-under-iso-13485)
- [How can benefits and risks be quantitatively assessed for imaging software under MDR?](https://openregulatory.com/questions/how-can-benefits-and-risks-be-quantitatively-assessed-for-imaging-software-under-mdr)
- [How to implement BSI TR-03161 and similar requirements in a QMS for DiGA?](https://openregulatory.com/questions/how-to-implement-bsi-tr-03161-and-similar-requirements-in-a-qms-for-diga)
- [Is it Formwork useful if not yet made a spin-out?](https://openregulatory.com/questions/is-it-formwork-useful-if-not-yet-made-a-spin-out)
- [Difference between MDR Annex IX and Annex XI for Class IIa Technical File Review](https://openregulatory.com/questions/difference-between-mdr-annex-ix-and-annex-xi-for-class-iia-technical-file-review)
- [How should substantial and significant changes be reported to notified bodies under MDR?](https://openregulatory.com/questions/how-should-substantial-and-significant-changes-be-reported-to-notified-bodies-under-mdr)
- [How to handle risk analysis for regression vs classification models in AI medical devices?](https://openregulatory.com/questions/how-to-handle-risk-analysis-for-regression-vs-classification-models-in-ai-medical-devices)
- [Is a saliva microbiome genetic test a medical device under IVDR?](https://openregulatory.com/questions/is-a-saliva-microbiome-genetic-test-a-medical-device-under-ivdr)
- [Is a 95,000€ IVDR certification quote typical for a small software manufacturer?](https://openregulatory.com/questions/is-a-95-000-ivdr-certification-quote-typical-for-a-small-software-manufacturer)
- [Labeling requirements for multiple models in FDA 510(k) submissions for software](https://openregulatory.com/questions/labeling-requirements-for-multiple-models-in-fda-510-k-submissions-for-software)
- [Can anyone recommend a consultant with experience writing a CIP for a Class IIb device?](https://openregulatory.com/questions/can-anyone-recommend-a-consultant-with-experience-writing-a-cip-for-a-class-iib-device)
- [How will the new EU AI Regulation affect conformity assessment for medical devices?](https://openregulatory.com/questions/how-will-the-new-eu-ai-regulation-affect-conformity-assessment-for-medical-devices)
- [Are there specific formatting requirements for GS1 field 8012?](https://openregulatory.com/questions/are-there-specific-formatting-requirements-for-gs1-field-8012)
- [How should changes to organizational details (e.g. CEO, company address) be tracked in a QMS under MDR?](https://openregulatory.com/questions/how-should-changes-to-organizational-details-e-g-ceo-company-address-be-tracked-in-a-qms-under-mdr)
- [Is AI used for image analysis in a medical device always classified as high-risk under the EU AI Act?](https://openregulatory.com/questions/is-ai-used-for-image-analysis-in-a-medical-device-always-classified-as-high-risk-under-the-eu-ai-act)
- [Have there been safety issues or field safety notices with AI-based medical devices?](https://openregulatory.com/questions/have-there-been-safety-issues-or-field-safety-notices-with-ai-based-medical-devices)
- [Tips for documenting SaMD compliance with the EU AI Act (Articles 4 & 5)](https://openregulatory.com/questions/tips-for-documenting-samd-compliance-with-the-eu-ai-act-articles-4-5)
- [How much harder is it to document Class C software than Class B](https://openregulatory.com/questions/how-much-harder-is-it-to-document-class-c-software-than-class-b)
- [EUDAMED and .xml Bulk Upload Files - How Do They Work?](https://openregulatory.com/questions/eudamed-and-xml-bulk-upload-files-how-do-they-work)
- [Documents mentioned in SOP Deployment ](https://openregulatory.com/questions/documents-mentioned-in-sop-deployment)
- [How should changes to a QMS unrelated to the product be tracked under MDR?](https://openregulatory.com/questions/how-should-changes-to-a-qms-unrelated-to-the-product-be-tracked-under-mdr)
- [How is medical device regulation developed and how can its usability be improved for start-ups?](https://openregulatory.com/questions/how-is-medical-device-regulation-developed-and-how-can-its-usability-be-improved-for-start-ups)
- [How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?](https://openregulatory.com/questions/how-should-ivdr-annex-i-article-9-1-a-requirements-be-addressed-for-samd-ivds-in-the-gspr)
- [Is it necessary to have technical documentation ready before certifying a QMS under MDR for a class IIa medical device?](https://openregulatory.com/questions/is-it-necessary-to-have-technical-documentation-ready-before-certifying-a-qms-under-mdr-for-a-class-iia-medical-device)
- [How do you validate and test your medical device IFU (Instructions For Use)?](https://openregulatory.com/questions/how-do-you-validate-and-test-your-medical-device-ifu-instructions-for-use)
- [Is it necessary to have technical documentation ready before certifying the QMS under MDR for a class IIa device?](https://openregulatory.com/questions/is-it-necessary-to-have-technical-documentation-ready-before-certifying-the-qms-under-mdr-for-a-class-iia-device)
- [What happens after the Substantive Review and AI response in the traditional 510(k) process?](https://openregulatory.com/questions/what-happens-after-the-substantive-review-and-ai-response-in-the-traditional-510-k-process)
- [Is reduced time to triage via telemedicine a clinical benefit under MDR?](https://openregulatory.com/questions/is-reduced-time-to-triage-via-telemedicine-a-clinical-benefit-under-mdr)
- [How are feature flags managed under IEC 62304 compliance?](https://openregulatory.com/questions/how-are-feature-flags-managed-under-iec-62304-compliance)
- [Are there general authentication requirements for patient mobile applications under MDR?](https://openregulatory.com/questions/are-there-general-authentication-requirements-for-patient-mobile-applications-under-mdr)
- [Is ISO 13485 certification still valid if the medical device is discontinued?](https://openregulatory.com/questions/is-iso-13485-certification-still-valid-if-the-medical-device-is-discontinued)
- [When is a QMS required for medical device development?](https://openregulatory.com/questions/when-is-a-qms-required-for-medical-device-development)
- [Is ISO 13485 certification required before CE marking for medical device software in the EU and Switzerland?](https://openregulatory.com/questions/is-iso-13485-certification-required-before-ce-marking-for-medical-device-software-in-the-eu-and-switzerland)
- [Should we send all our developers to multi-day 8-hour "training sessions" for e.g. the ISO 13485?](https://openregulatory.com/questions/should-we-send-all-our-developers-to-multi-day-8-hour-training-sessions-for-e-g-the-iso-13485)
- [IEC 82304: How Is It Different From The IEC 62304?](https://openregulatory.com/questions/iec-82304-how-is-it-different-from-the-iec-62304)
- [What's The Best QMS Software?](https://openregulatory.com/questions/best-qms-software)
- [Formative vs. Summative Usability Testing - What's The Difference?](https://openregulatory.com/questions/formative-vs-summative-usability-testing-whats-the-difference)
- [When Should We Start Documenting Our Medical Device And QMS?](https://openregulatory.com/questions/when-should-we-start-documenting-our-medical-device-and-qms)
- [Manual Tests vs. Automated Tests For Medical Device Software](https://openregulatory.com/questions/manual-tests-vs-automated-tests-for-medical-device-software)
- [Which Notified Body Should We Choose?](https://openregulatory.com/questions/which-notified-body-should-we-choose)
- [In-House Devices Under The MDR](https://openregulatory.com/questions/in-house-devices-under-the-mdr)
- [Flowcharts For ISO 13485: Should We Add Flowcharts To SOPs?](https://openregulatory.com/questions/flowcharts-for-iso-13485-should-we-add-flowcharts-to-sops)
- [Can We Integrate Our eQMS With Jira, GitHub, Sharepoint, etc.?](https://openregulatory.com/questions/can-we-integrate-our-eqms-with-jira-github-sharepoint-etc)
- [Can We Document Our Software After We've Developed It?](https://openregulatory.com/questions/can-we-document-our-software-after-weve-developed-it)
- [Should We Use Short Or Lengthy Templates For Medical Device Compliance?](https://openregulatory.com/questions/should-we-use-short-or-lengthy-templates-for-medical-device-compliance)
- [How Much Does Medical Device Compliance Cost?](https://openregulatory.com/questions/how-much-does-medical-device-compliance-cost)
- [How Long Does Medical Device Compliance Take?](https://openregulatory.com/questions/how-long-does-medical-device-compliance-take)
- [Which QMS Software Should We Choose?](https://openregulatory.com/questions/which-qms-software-should-we-choose)
- [Can We Do Agile Development For Our Medical Device Software?](https://openregulatory.com/questions/can-we-do-agile-development-for-our-medical-device-software)
- [How To Do Medical Device Software Development?](https://openregulatory.com/questions/how-to-do-medical-device-software-development)
- [We're In A Rush. Can We Automate Our Technical Documentation Completely?](https://openregulatory.com/questions/were-in-a-rush-can-we-automate-our-technical-documentation-completely)
- [Which Data Should We Collect In Our Post-Market Surveillance?](https://openregulatory.com/questions/which-data-should-we-collect-in-our-post-market-surveillance)
- [Should We Register Our Algorithm As a Patent?](https://openregulatory.com/questions/should-we-register-software-as-a-patent)
- [What Is Clinical Evidence (MDR)?](https://openregulatory.com/questions/what-is-mdr-clinical-evidence)
- [How To Find Out Whether Your Regulatory Consultant Sucks](https://openregulatory.com/questions/how-to-find-out-whether-your-regulatory-consultants-sucks)
- [How To Analyze And Report "Trends" Under The MDR?](https://openregulatory.com/questions/mdr-analyze-report-trends)
- [What Is a Clinical Development Plan?](https://openregulatory.com/questions/mdr-clinical-evaluation-clinical-development-plan)
- [How Do We Certify API-Only Software As a Medical Device?](https://openregulatory.com/questions/certify-api-only-software-as-a-medical-device)
- [What Is "FDA 21 CFR Part 820" Compliant eQMS Software?](https://openregulatory.com/questions/what-is-fda-21-cfr-part-820-eqms-software)
- [What's the Minimum Number of Users for a Usability Test?](https://openregulatory.com/questions/minimum-number-users-usability-test-iec-62366)
- [What is a MDR UDI? Unraveling the Importance of Unique Device Identification](https://openregulatory.com/questions/what-is-a-mdr-udi)
- [What is IFA?](https://openregulatory.com/questions/what-is-ifa-udi)
- [What is a GS1? Shedding light on the UDI provider](https://openregulatory.com/questions/what-is-a-gs1-shedding-light-on-the-udi-provider)
- [What's the Difference Between a Document and a Record?](https://openregulatory.com/questions/difference-between-qms-document-and-record)
- [How To Create a QMS in Sharepoint: Complete Guide + Don't Do It](https://openregulatory.com/questions/set-up-qms-in-microsoft-sharepoint)
- [Should We Choose Our Cloud Provider Based on Free Credits?](https://openregulatory.com/questions/choose-cloud-provider-based-on-free-credits)
- [Can We Bring a Lifestyle Device to Market First?](https://openregulatory.com/questions/bring-medical-device-to-market-as-lifestyle-device-first)
- [QMS Software And Jira / GitHub / GitLab Integrations: Don't Make a Mistake!](https://openregulatory.com/questions/qms-software-jira-github-gitlab-integration-mistake)
- [Do We Need AI / Machine Learning Consultants?](https://openregulatory.com/questions/do-we-need-ai-machine-learning-deep-learning-medical-device-consultants)
- [Should You Do a BfArM Classification Request? The Answer Is No.](https://openregulatory.com/questions/bfarm-classification-request-train-wreck)
- [How Can We Set Up a QMS in Confluence / Jira?](https://openregulatory.com/questions/set-up-qms-in-confluence-jira)
- [As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?](https://openregulatory.com/questions/mdr-class-i-competent-authority-hamburg-munich-berlin)
- [Do We Need a User Manual for Our Software as a Medical Device?](https://openregulatory.com/questions/do-we-need-user-manual-software-medical-device)
- [Should We Develop Our Software Or Set Up Our QMS First?](https://openregulatory.com/questions/develop-software-or-set-up-qms-first)
- [MDR Class 1 Devices: Do They Exist (as software)?](https://openregulatory.com/questions/do-software-mdr-class-1-devices-exist)
- [What's the Definition of a Medical Device According to the MDR?](https://openregulatory.com/questions/medical-device-definition-mdr)
- [Is Our Software a Medical Device (and Do We Need to Certify It)?](https://openregulatory.com/questions/is-our-software-medical-device)
- [Do We Have to Read Those Boring Standards?](https://openregulatory.com/questions/do-we-have-to-read-boring-standards)
- [Software as a Medical Device: What's a Significant Change?](https://openregulatory.com/questions/medical-device-significant-change)
- [How Do SemVer Versions Map to Significant Changes for a Medical Device?](https://openregulatory.com/questions/semver-significant-change-medical-device)
- [Machine Learning Software as a Medical Device: Can We Update Our Model?](https://openregulatory.com/questions/machine-learning-software-medical-device-update-model)
- [Should You Automate Your Software Architecture Documentation?](https://openregulatory.com/questions/automate-software-architecture-documentation)
- [Can We Use GitHub and Other SaaS For Our Software as a Medical Device?](https://openregulatory.com/questions/use-saas-github-software-medical-device)
- [Do We Have to Re-Do All Software System Tests After a Minor Change?](https://openregulatory.com/questions/redo-software-system-tests-after-minor-change)
- [Do Auditors Read Your Code?](https://openregulatory.com/questions/do-auditors-read-your-code)
- [Do You Need Video Cameras For User Testing?](https://openregulatory.com/questions/video-cameras-for-user-testing-iec-62366)
- [Software Validation Procedure for ISO 13485 compliance?](https://openregulatory.com/questions/software-validation-procedure-iso-13485)
- [How to document SOUP for IEC 62304 compliance?](https://openregulatory.com/questions/how-to-document-soup-iec-62304)

## Optional

## Videos
- [eQMS MCP Server: Talk to Your QMS! (OpenRegulatory Formwork)](https://openregulatory.com/videos/eqms-mcp-server-talk-to-your-qms-openregulatory-formwork)
- [AI-Generate Your QMS + Technical Documentation in 3 Minutes](https://openregulatory.com/videos/ai-generate-your-qms-technical-documentation-in-3-minutes)
- [Free ISO 19011 Internal Auditor Training (for Medical Devices)](https://openregulatory.com/videos/free-iso-19011-internal-auditor-training-for-medical-devices)
- [Free MDR PRRC Course (Person Responsible for Regulatory Compliance)](https://openregulatory.com/videos/free-mdr-prrc-course-person-responsible-for-regulatory-compliance)
- [Medizinprodukteberater Course: Examples](https://openregulatory.com/videos/medizinprodukteberater-course-examples)
- [Medizinprodukteberater Course: Requirements, Tasks, Responsibilities](https://openregulatory.com/videos/medizinprodukteberater-course-requirements-tasks-responsibilities)
- [Post-Market Surveillance: The Periodic Safety Update Report (PSUR)](https://openregulatory.com/videos/post-market-surveillance-the-periodic-safety-update-report-psur)
- [Medical Device Post-Market Surveillance: The Plan](https://openregulatory.com/videos/medical-device-post-market-surveillance-the-plan)
- [Medical Device Post-Market Surveillance: The Process](https://openregulatory.com/videos/medical-device-post-market-surveillance-the-process)
- [Free Medical Device Post-Market Surveillance Course: Concepts](https://openregulatory.com/videos/free-medical-device-post-market-surveillance-course-concepts)
- [Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)](https://openregulatory.com/videos/post-market-clinical-follow-up-the-report-medical-device-clinical-evaluation)
- [Post-Market Clinical Follow-up: Concepts and Plan](https://openregulatory.com/videos/post-market-clinical-follow-up-concepts-and-plan)
- [Clinical Evaluation: Post-Market Surveillance (PMS) Database Search](https://openregulatory.com/videos/clinical-evaluation-post-market-surveillance-pms-database-search)
- [Literature Search For Clinical Evaluation of Medical Devices](https://openregulatory.com/videos/literature-search-for-clinical-evaluation-of-medical-devices)
- [Clinical Evaluation: The Clinical Evaluation Report (CER)](https://openregulatory.com/videos/clinical-evaluation-the-clinical-evaluation-report-cer)
- [Clinical Evaluation: Understanding the Phases and the Plan](https://openregulatory.com/videos/clinical-evaluation-understanding-the-phases-and-the-plan)
- [Free Clinical Evaluation Course, Part 1: Understanding the Process](https://openregulatory.com/videos/free-clinical-evaluation-course-part-1-understanding-the-process)
- [Registering Your UDI in EUDAMED (Medical Device Database)](https://openregulatory.com/videos/registering-your-udi-in-eudamed-medical-device-database)
- [Creating a UDI-PI and Data Matrix Code at IFA](https://openregulatory.com/videos/creating-a-udi-pi-and-data-matrix-code-at-ifa)
- [Generating the Basic UDI-DI at IFA](https://openregulatory.com/videos/generating-the-basic-udi-di-at-ifa)
- [Hack: UDI-DI for Free with HPC at IFA (for Medical Devices)](https://openregulatory.com/videos/hack-udi-di-for-free-with-hpc-at-ifa-for-medical-devices)
- [IFA: Ordering a PPN via Auftragstabelle B3](https://openregulatory.com/videos/ifa-ordering-a-ppn-via-auftragstabelle-b3)
- [Registering As a Customer at IFA to Create a UDI](https://openregulatory.com/videos/registering-as-a-customer-at-ifa-to-create-a-udi)
- [Creating a Medical Device UDI at IFA (Unique Device Identifier)](https://openregulatory.com/videos/creating-a-medical-device-udi-at-ifa-unique-device-identifier)
- [UDI-PI and Barcode With Application Identifiers in GS1](https://openregulatory.com/videos/udi-pi-and-barcode-with-application-identifiers-in-gs1)
- [Creating the Basic UDI-DI as GMN in GS1](https://openregulatory.com/videos/creating-the-basic-udi-di-as-gmn-in-gs1)
- [How to Use The GS1 GTIN Manager (UDIs for Medical Devices)](https://openregulatory.com/videos/how-to-use-the-gs1-gtin-manager-udis-for-medical-devices)
- [Registering a UDI with GS1 (Unique Device Identifiers for Medical Devices)](https://openregulatory.com/videos/registering-a-udi-with-gs1-unique-device-identifiers-for-medical-devices)
- [Free Course: Understanding Unique Device Identifiers (UDIs) For Medical Devices](https://openregulatory.com/videos/free-course-understanding-unique-device-identifiers-udis-for-medical-devices)
- [Software Validation (ISO 13485 QMS), Part 2](https://openregulatory.com/videos/software-validation-iso-13485-qms-part-2)
- [Software Validation (as part of your QMS, for the ISO 13485)](https://openregulatory.com/videos/software-validation-as-part-of-your-qms-for-the-iso-13485)
- [Purchasing: Supplier Checklist For ISO 13485 Compliance](https://openregulatory.com/videos/purchasing-supplier-checklist-for-iso-13485-compliance)
- [Purchasing SOP For Medical Devices (ISO 13485)](https://openregulatory.com/videos/purchasing-sop-for-medical-devices-iso-13485)
- [Human Resources Administration For Medical Device Companies (ISO 13485)](https://openregulatory.com/videos/human-resources-administration-for-medical-device-companies-iso-13485)
- [Vigilance For EU MDR and ISO 13485 Compliance](https://openregulatory.com/videos/vigilance-for-eu-mdr-and-iso-13485-compliance)
- [CAPAs (Corrective and Preventive Actions) For ISO 13485 Compliance](https://openregulatory.com/videos/capas-corrective-and-preventive-actions-for-iso-13485-compliance)
- [EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)](https://openregulatory.com/videos/eu-mdr-post-market-surveillance-part-2-iso-13485)
- [Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates](https://openregulatory.com/videos/medical-device-technical-documentation-in-5-minutes-formwork-product-templates)
- [QMS Automation With The Formwork QMS Overview](https://openregulatory.com/videos/qms-automation-with-the-formwork-qms-overview)
- [Medical Device QMS Software Comparison: Shady Business Practices!](https://openregulatory.com/videos/medical-device-qms-software-comparison-shady-business-practices)
- [Agile Development For Medical Device Software: Is It Possible?](https://openregulatory.com/videos/agile-development-for-medical-device-software-is-it-possible)
- [Get Notified About Regulatory Updates](https://openregulatory.com/videos/get-notified-about-regulatory-updates)
- [Jira QMS: Can You Set Up a QMS And Requirements Management In Jira For Medical Device Compliance?](https://openregulatory.com/videos/jira-qms-can-you-set-up-a-qms-and-requirements-management-in-jira-for-medical-device-compliance)
- [Get The ISO 13485 Almost For Free: How to Buy Standards on the Estonian Website](https://openregulatory.com/videos/get-the-iso-13485-almost-for-free-how-to-buy-standards-on-the-estonian-website)
- [Bringing Transparency To MDR Compliance](https://openregulatory.com/videos/bringing-transparency-to-mdr-compliance)
- [Free MDR Templates](https://openregulatory.com/videos/free-mdr-templates)
- [Software Detailed Design Documentation in Formwork](https://openregulatory.com/videos/software-detailed-design-documentation-in-formwork)
- [MDR Clinical Evaluation: Understanding the Process](https://openregulatory.com/videos/mdr-clinical-evaluation-understanding-the-process)
- [QMS Overview: Automate Your ISO 13485 Documents and Records](https://openregulatory.com/videos/qms-overview-automate-your-iso-13485-documents-and-records)
- [Use ChatGPT to Generate Your QMS In Minutes](https://openregulatory.com/videos/use-chatgpt-to-generate-your-qms-in-minutes)
- [Custom File Documents / Records](https://openregulatory.com/videos/custom-file-documents-records)
- [QMS Trainings: Automatically Train Your Employees in Formwork](https://openregulatory.com/videos/qms-trainings-automatically-train-your-employees-in-formwork)
- [Formwork Batch Export: The Only eQMS Software Without Lock-In](https://openregulatory.com/videos/formwork-batch-export-the-only-eqms-software-without-lock-in)
- [Manage your Technical Documentation in Formwork (eQMS software)](https://openregulatory.com/videos/manage-your-technical-documentation-in-formwork-eqms-software)
- [ChatGPT For Medical Devices And Automating QMS Trainings](https://openregulatory.com/videos/chatgpt-for-medical-devices-and-automating-qms-trainings)
- [Auto-Generate Audit Spreadsheets For Requirements Management](https://openregulatory.com/videos/auto-generate-audit-spreadsheets-for-requirements-management)
- [Save Time By Copying OpenRegulatory Templates](https://openregulatory.com/videos/save-time-by-copying-openregulatory-templates)
- [How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants](https://openregulatory.com/videos/how-to-get-regulatory-work-done-fast-hiring-eqms-software-consultants)
- [What Do You Need To Do? Looking At IEC 62304 And Other Docs](https://openregulatory.com/videos/what-do-you-need-to-do-looking-at-iec-62304-and-other-docs)
- [Medical Device Compliance: Cost & Duration](https://openregulatory.com/videos/medical-device-compliance-cost-duration)
- [Getting a MDR UDI From IFA](https://openregulatory.com/videos/getting-a-mdr-udi-from-ifa)
- [Getting a MDR UDI from GS1](https://openregulatory.com/videos/getting-a-mdr-udi-from-gs1)
- [Meet CrowdCovid (Example Medical Device Software For IEC 62304 Compliance)](https://openregulatory.com/videos/meet-crowdcovid-example-medical-device-software-for-iec-62304-compliance)
- [Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)](https://openregulatory.com/videos/getting-started-with-the-iec-62366-usability-engineering-for-software-as-a-medical-device)
- [How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?](https://openregulatory.com/videos/how-does-the-iec-62304-v-model-work-for-software-development-of-medical-devices)
- [Medical Device Software Development: Introduction To The IEC 62304](https://openregulatory.com/videos/medical-device-software-development-introduction-to-the-iec-62304)
- [Introduction To MDR UDIs](https://openregulatory.com/videos/introduction-to-mdr-udis)
- [Hardware Medical Devices in Formwork](https://openregulatory.com/videos/hardware-medical-devices-in-formwork)
- [Formwork vs  GitHub, Jira, ClickUp, Asana](https://openregulatory.com/videos/formwork-vs-github-jira-clickup-asana)
- [AI-Assisted Writing of Technical Documentation](https://openregulatory.com/videos/ai-assisted-writing-of-technical-documentation)
- [Manage Your Medical Device CAPAs in Formwork (eQMS)](https://openregulatory.com/videos/manage-your-medical-device-capas-in-formwork-eqms)
- [Formwork: Auto-Generate Your Technical Documentation With The New Audit Export](https://openregulatory.com/videos/formwork-auto-generate-your-technical-documentation-with-the-new-audit-export)
- [Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)](https://openregulatory.com/videos/document-and-record-control-for-medical-device-quality-management-systems-iso-13485-qms)
- [Internal Audit For Medical Device Manufacturers (ISO 13485 Compliance)](https://openregulatory.com/videos/internal-audit-for-medical-device-manufacturers-iso-13485-compliance)
- [Writing a Quality Manual For Medical Device Quality Management (ISO 13485)](https://openregulatory.com/videos/writing-a-quality-manual-for-medical-device-quality-management-iso-13485)
- [The Magical Wizard and How It Helps You](https://openregulatory.com/videos/the-magical-wizard-and-how-it-helps-you)
- [SaMD Meetup #11: Post-Market Surveillance](https://openregulatory.com/videos/samd-meetup-11-post-market-surveillance)
- [Automate Your Medical Device Risk Management With Formwork, An eQMS (ISO 14971 Compliance)](https://openregulatory.com/videos/automate-your-medical-device-risk-management-with-formwork-an-eqms-iso-14971-compliance)
- [Audit Export and Sanity Check](https://openregulatory.com/videos/audit-export-and-sanity-check)
- [IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD)](https://openregulatory.com/videos/iec-62304-compliant-software-requirements-specification-for-software-as-a-medical-device-samd)
- [Employee QMS Training For ISO 13485 Compliance, Using eQMS Software](https://openregulatory.com/videos/employee-qms-training-for-iso-13485-compliance-using-eqms-software)
- [ISO 13485 - Compliant Handling Of Records, Save Time Using OpenRegulatory Templates](https://openregulatory.com/videos/iso-13485-compliant-handling-of-records-save-time-using-openregulatory-templates)
- [FDA and EU - Complaint E-Signatures: Documents and Review Workflow in eQMS Software Formwork](https://openregulatory.com/videos/fda-and-eu-complaint-e-signatures-documents-and-review-workflow-in-eqms-software-formwork)
- [Introducing Formwork](https://openregulatory.com/videos/introducing-formwork)
- [OpenRegulatory Workshop at Digital Medicine Conference 2021](https://openregulatory.com/videos/openregulatory-workshop-at-digital-medicine-conference-2021)
- [Documenting Failure Modes for ISO 14971 (Risk Management For Medical Devices)](https://openregulatory.com/videos/documenting-failure-modes-for-iso-14971-risk-management-for-medical-devices)
- [Failure Mode and Effects Analysis (FMEA) for ISO 14971 (Risk Management For Medical Devices)](https://openregulatory.com/videos/failure-mode-and-effects-analysis-fmea-for-iso-14971-risk-management-for-medical-devices)
- [Creating a Simple Risk Table for ISO 14971 (Risk Management For Medical Devices)](https://openregulatory.com/videos/creating-a-simple-risk-table-for-iso-14971-risk-management-for-medical-devices)
- [Creating a List of Hazard-Related Use Scenarios for IEC 62366 (Usability For Medical Devices)](https://openregulatory.com/videos/creating-a-list-of-hazard-related-use-scenarios-for-iec-62366-usability-for-medical-devices)
- [Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)](https://openregulatory.com/videos/preparing-the-usability-evaluation-protocol-for-iec-62366-medical-device-compliance)
- [Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance)](https://openregulatory.com/videos/writing-a-software-development-and-maintenance-plan-for-iec-62304-medical-device-compliance)
- [Documenting Software of Unknown Provenance (SOUP) for IEC 62304](https://openregulatory.com/videos/documenting-software-of-unknown-provenance-soup-for-iec-62304)
- [Dr. Oliver Eidel bei der Digital Medicine Week 2021 vom health innovation hub (hih)](https://openregulatory.com/videos/dr-oliver-eidel-bei-der-digital-medicine-week-2021-vom-health-innovation-hub-hih)
- [Free Course: Quality Management For Medical Devices (ISO 13485 QMS)](https://openregulatory.com/videos/free-course-quality-management-for-medical-devices-iso-13485-qms)
- [Free Usability Engineering Course (Medical Devices - IEC 62366)](https://openregulatory.com/videos/free-usability-engineering-course-medical-devices-iec-62366)
- [Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971)](https://openregulatory.com/videos/free-medical-device-risk-management-course-introduction-simple-risk-table-iso-14971)
- [Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD)](https://openregulatory.com/videos/free-iec-62304-course-documenting-software-as-a-medical-device-samd)
- [ChatGPT For Medical Device Documentation (MDR / FDA)?](https://openregulatory.com/videos/chatgpt-for-medical-device-documentation-mdr-fda)
- [Leander Märkisch: Building AI For Radiology at Floy (Healthcare Startup Meetup #1)](https://openregulatory.com/videos/leander-markisch-building-ai-for-radiology-at-floy-healthcare-startup-meetup-1)
- [Document and Record Control For The ISO 13485](https://openregulatory.com/videos/document-and-record-control-for-the-iso-13485)
- [Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366)](https://openregulatory.com/videos/medical-device-usability-engineering-writing-user-tests-summative-evaluation-of-iec-62366)
- [Medical Device Risk Analysis: Risk Matrix (ISO 14971)](https://openregulatory.com/videos/medical-device-risk-analysis-risk-matrix-iso-14971)
- [AI QMS: Where ChatGPT Fails (Cybersecurity Requirements)](https://openregulatory.com/videos/ai-qms-where-chatgpt-fails-cybersecurity-requirements)
- [Actually Getting The Standard (IEC 62304 Course Episode 2)](https://openregulatory.com/videos/actually-getting-the-standard-iec-62304-course-episode-2)
- [Matthew Fenech: DiGA For Glucose Control at Una Health (Healthcare Startup Meetup #2)](https://openregulatory.com/videos/matthew-fenech-diga-for-glucose-control-at-una-health-healthcare-startup-meetup-2)
- [Certification and Product Registration Process](https://openregulatory.com/videos/certification-and-product-registration-process)
- [Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366)](https://openregulatory.com/videos/doing-the-summative-usability-evaluation-user-tests-medical-device-compliance-iec-62366)
- [Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971)](https://openregulatory.com/videos/risk-tables-are-easy-medical-device-risk-analysis-iso-14971)
- [ChatGPT QMS For Editing Documents (Fix Audit Findings)](https://openregulatory.com/videos/chatgpt-qms-for-editing-documents-fix-audit-findings)
- [Understanding the IEC 62304 Safety Classes and the Mysterious V-Model](https://openregulatory.com/videos/understanding-the-iec-62304-safety-classes-and-the-mysterious-v-model)
- [B2B Sales And Generating Revenue: Tatyana Eliseeva, Healthcare Startup Meetup #3](https://openregulatory.com/videos/b2b-sales-and-generating-revenue-tatyana-eliseeva-healthcare-startup-meetup-3)
- [Management Reviews For ISO 13485 Compliance (Medical Devices)](https://openregulatory.com/videos/management-reviews-for-iso-13485-compliance-medical-devices)
- [Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices)](https://openregulatory.com/videos/formative-evaluation-for-usability-compliance-iec-62366-for-medical-devices)
- [Medical Device Failure Modes (ISO 14971 Risk Analysis)](https://openregulatory.com/videos/medical-device-failure-modes-iso-14971-risk-analysis)
- [Risk Management With AI: 1,000x faster! (in seconds)](https://openregulatory.com/videos/risk-management-with-ai-1-000x-faster-in-seconds)
- [Writing Software Requirements For IEC 62304 Compliance](https://openregulatory.com/videos/writing-software-requirements-for-iec-62304-compliance)
- [Internal Audits (ISO 13485 Compliance)](https://openregulatory.com/videos/internal-audits-iso-13485-compliance)
- [Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366)](https://openregulatory.com/videos/usability-evaluation-plan-report-finalizing-medical-device-usability-compliance-iec-62366)
- [Risk Controls Make Your Life Easier (Medical Device Risk Management)](https://openregulatory.com/videos/risk-controls-make-your-life-easier-medical-device-risk-management)
- [AI-Powered eQMS: 100x Faster Trainings!](https://openregulatory.com/videos/ai-powered-eqms-100x-faster-trainings)
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- [Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)](https://openregulatory.com/videos/linking-up-failure-modes-and-risk-controls-medical-device-risk-analysis)
- [Documenting SOUP (Software of Unknown Provenance) For IEC 62304 and Medical Device Compliance](https://openregulatory.com/videos/documenting-soup-software-of-unknown-provenance-for-iec-62304-and-medical-device-compliance)
- [EU MDR Post-Market Surveillance, Part 1 (+ ISO 13485)](https://openregulatory.com/videos/eu-mdr-post-market-surveillance-part-1-iso-13485)
- [Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)](https://openregulatory.com/videos/hazard-related-use-scenarios-risk-analysis-for-medical-devices-usability-engineering)
- [Writing a Software Development and Maintenance Plan For IEC 62304 Compliance](https://openregulatory.com/videos/writing-a-software-development-and-maintenance-plan-for-iec-62304-compliance)
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- [IEC 62304 - Compliant Software Development Process (SOP Software Development)](https://openregulatory.com/videos/iec-62304-compliant-software-development-process-sop-software-development)
- [ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report](https://openregulatory.com/videos/iso-14971-wrap-up-sanity-check-ai-descriptions-risk-management-plan-report)
- [Software Architecture For Medical Device Software (IEC 62304 Compliance)](https://openregulatory.com/videos/software-architecture-for-medical-device-software-iec-62304-compliance)
- [Software Release and Review: Final Tasks For IEC 62304 Compliance For Software as  Medical Device](https://openregulatory.com/videos/software-release-and-review-final-tasks-for-iec-62304-compliance-for-software-as-medical-device)
- [Change Management For Software as a Medical Device (IEC 62034 Compliance)](https://openregulatory.com/videos/change-management-for-software-as-a-medical-device-iec-62034-compliance)
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