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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). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages.

Bibliographic Details
Main Author: Juuso, Ilkka
Corporate Author: Taylor & Francis
Other Authors: Pöyhönen, Ilpo
Format: eBook
Language:English
Published: Milton : Productivity Press, 2023.
Subjects:
Medical instruments and apparatus > Design and construction > Standards.
Medical instruments and apparatus > Design and construction > Safety measures.
Medical instruments and apparatus > Quality control > Standards.
Médecine > Appareils et instruments > Qualité > Contrôle > Normes.
BUSINESS & ECONOMICS / Quality Control
TECHNOLOGY / Manufacturing
BUSINESS & ECONOMICS / Production & Operations Management
Electronic books.
Online Access:Connect to the full text of this electronic book
Description
Summary: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.
Item Description:Description based upon print version of record.
Physical Description:1 online resource (367 p.)
ISBN:9781000987881
1000987884
9781003454830
1003454836
9781000987904
1000987906