How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485
Omschrijving
This book is a practical guide to meeting IEC 62304 software development requirements within the context of an ISO 13485 quality management system (QMS). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages.
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‘Medical-Grade Software Development - Juuso, Ilkka, Poyhonen, Ilpo’.
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