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ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control

Mr Brendan Cooper

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ISBN 10: 1545382379 / ISBN 13: 9781545382370
Published by CreateSpace Independent Publishing Platform, 2017
New Condition: New Soft cover
From Books Express (Portsmouth, NH, U.S.A.)

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Bibliographic Details

Title: ISO 13485 - the Quality Management System ...

Publisher: CreateSpace Independent Publishing Platform

Publication Date: 2017

Binding: Paperback

Book Condition: New

Edition: 01.

About this title


This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis’ of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics or those wishing to have a physical resource.

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