Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485 - Paperback
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Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485
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...
Dr. Ilkka Juuso, DSc, has 20-plus years of experience working on multidisciplinary R&D projects in both industry and academia. He is one of the founders of the medical device startup Cerenion, a Senior Advisor with the medical device quality consultancy Kasve, and a post-doctoral researcher with the University of Oulu.
His main interests are international regulatory affairs, standardization,...
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