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Cover of Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of Iec 62304 and ISO 13485
  • ISBN-13 · 9781032594729
  • ISBN-10 · 1032594721
  • Publisher · Productivity Press
  • Format · Trade Paperback, 338 pages
  • Published · 2023
  • Language · English

Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of Iec 62304 and ISO 13485

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About this book

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.

Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of Iec 62304 and ISO 13485 by Juuso, Ilkka, P�yh�nen, Ilpo — Bookface