Applied Human Factors in Medical Device Design
W**K
Must have book for anyone working in Medical Devices Human Factors/regulatory compliance
This book is a systematic guide to human factors processes in medical device development from product discovery to post market surveillance. It is largely based on HE75 and ISO 62366, so covers FDA and EU requirements, although as it is by the AAMI it is more US focused. That said the methodology is just as useful for other none regulated industries.This book however will not give best practice data in relation to biomechanics or anthropometric etc, You will need other references for that This is purely methodology. But it explains that very well.Recommended.
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