Follow The FDA Guidance Documents |
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| Written by Graham Stoney |
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Some of the medical device regulators have gone to some trouble to give their guidance on how to make your job easier, and it's well worth following it. This is a bit like “do what your mum told you”. Take their advice. I highly recommend these FDA guidance documents related to software development. They contain great practical advice, and are required reading if you want to make your life easier: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Although the title talks about Premarket Submissions, the content hints very strongly that if you approach and structure your development according to their recommendations, it will be much, much easier to generate the information in your regulatory submissions proving that your device is safe and effective. So this document isn't just for your regulatory department; engineers should read it too. General Principles of Software Validation; Final Guidance for Industry and FDA Staff More essential reading, particularly for people involved in software testing, but also for all engineers involved in design for testability. (And if your recruitment screening is working, that means every engineer in your organisation). Again, follow their advice and life will be much easier come audit time. Also notice what this document says about doing design reviews. Social Bookmark this page:          |