Medical-Grade Software Development

How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485

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This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible.By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-softw...