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GS1 provides “one global system” for product identification. It’s a company that sells numbers to businesses. Those numbers help identify the products
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Documents describe how things should be done. They have a version history and they require a proper review process when updated. Records on the other
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Don’t do it. Setting up a QMS in Sharepoint is probably the worst thing which could happen to you and your company. It will make your life a living he
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No. Choose whatever cloud provider is the most suitable for you on a technical level. Most commonly, that’s not the provider that throws around free c
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Yes! With some limitations though. The most important one is that the product which you bring to market must not fulfil the definition of a medical d
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Hell no! The medical device consultant industry is shady as hell, and medical device machine learning consultants are no exception. I have indirectl
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What you’re looking for doesn’t exist. Even if you had a perfect QMS software with a perfect Jira / GitHub integration, it wouldn’t help you very much
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If you think your device is a MDR class I device, you have three options: • Just bring it to market and wait for a surprise audit by the (state) co
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Don’t do it. Jira sucks, and Confluence sucks, too. I don’t see how any rational human could choose these tools for daily use unless being blackmailed
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Yes, probably. Long Answer Some quick background information first! (By the way, if you're interested in a summary of MDR class I in general, check
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Our recommended strategy for MDR class I and IIa would be this: • Have an electronic user manual which is accessible in your app by e.g. linking to
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Develop your software first. We are the only consultants with this opinion (other consultants disagree heavily). But then again, we seem to be the onl
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Yes. Two examples come to mind: Software for the (primary) prevention of disease, and software for directly treating a disease. It boils down to readi
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Don’t expect a short answer when I’m about to cite regulations. Long Answer In the MDR article 2, section 1, it says: “medical device” means any ins
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Yes. Read the standards. Long Answer Some founders ask me whether they have to read the boring standards, e.g. the ISO 13485 (quick note: here's our
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It depends. Think about what your software does, consider writing this down (it’s called an intended use). Then, read the definition of a medical devi
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Generally speaking, most Notified Bodies don't classify a machine learning model update as a significant change if your performance improves and your
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There is no short answer. It’s a mess and depends on your auditor, that is, if you can reach them. There’s the MDCG 2020-3 guidance document which c
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No. You can increment whatever number you want. It depends entirely on the content of the change, not your version number. See my answer on significan
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No, not necessarily. Only re-do the tests for software requirements which were touched by the (code) change. But be sure to document your reasoning. L