Questions

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In my case, I don't have a separate SOP for this type of change, but I mention it in the management SOP and keep a record for tracking process changes

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Regulation like the MDR is developed at the EU level as part of the "new legislative framework" for product safety. The process involves EU institutio

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You're right that not all aspects of Article 9.1(a) make sense for SaMD-IVDs, but it's generally not correct to mark the entire requirement as 'not ap

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It's generally fine to proceed with certifying your QMS before the technical documentation for your device is complete, especially if you are aiming f

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We've written a questionnaire with about 5-6 questions for users to answer after reviewing the IFU. The main focus is whether the instructions are cle

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Certification to ISO 13485 is independent from being a manufacturer under MDR Annex IX. Many certification bodies are not Notified Bodies for MDR, so

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After you submit your response to the AI request, the FDA generally has 30 days to review it and make a decision. If they have additional questions, t

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I think you can definitely argue that reduced time to triage is a clinical benefit, since the MDR includes positive impact on patient management in it

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Feature flags are generally considered a configuration, not a new release of the software. However, you must ensure that all possible configurations e

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Overall, MDR does not specify detailed authentication requirements for patient mobile applications. The MDCG cybersecurity guidance mainly suggests us

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ISO 13485 certification is company-specific and not tied to a specific device. You can keep your ISO 13485 certification even if you don't have an act

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Ideally, you would have your QMS in place before the development phase starts. In reality, most companies implement it during the development phase, s

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One of the requirements for CE marking, depending on the classification of your device, is that you have a certified QMS in place. The MDR requires ma

Short answer: No, none of this makes sense. Your two most likely options are: • Convince the CEO that this is a huge mistake, save the company, and st

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Don't worry about it. Auditors won't like me for saying this, but the 82304 doesn't contain much additional content on top of the 62304. Just comply w

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If you're a startup and don't know much about regulatory compliance yet, postpone that decision for now and learn a bit more about regulatory complian

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For summative usability testing, you need to do a user test (5 users or more in the EU, 15 in the US). For formative usability testing, you can "what

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If your software is not done yet, the most efficient approach in 95% of cases is to wait until your first version is done. For some reason, most peopl

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Do manual testing. I know it sucks, but it's more straightforward for many reasons. Long Answer Let me start off with this: I'm a software engineer m

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DQS, BerlinCert, or maybe one of the lesser-known ones in Eastern Europe, in that order. Avoid BSI and Tüv Süd. Subjective opinion. Long Answer Discl