Questions

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No. Do it manually. Long Answer Your software architecture diagram should be on a rather high level (see the example here). It’ll be really hard to a

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Your consultant is wrong. You can use GitHub. And look for another consultant. Long Answer The ISO 13485 requires you to “validate” all quality-relev

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No, your auditor won’t read your code. Long Answer Think about it this way: The probability of your auditor being a software developer is low (yes, I

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No, you don’t need video and screen recordings. Long Answer There are no hard requirements for user testing. At minimum, you need some sort of proof

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Don’t panic :) Yes, you have to validate software and it feels like overhead, but it’s manageable and not a huge effort. Write down your intended use

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You need to create a list of your dependencies. That list can be a spreadsheet, a markdown file, or pretty much anything else which you can save as do