Practical Design Control Implementation for Medical Devices

1st Edition

Jose Justiniano, Venky Gopalaswamy

CRC Press
Published March 12, 2003
Reference - 232 Pages
ISBN 9781574911275 - CAT# PH1279

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Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.


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