Practical Design Control Implementation for Medical Devices

Justiniano, Jose; Gopalaswamy, Venky

ISBN 10: 1574911279 ISBN 13: 9781574911275

Published by CRC Press, 2003

Language: English

Condition: New Hardcover

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Bibliographic Details

Title

Practical Design Control Implementation for Medical Devices

Publisher

CRC Press

Publication Date

2003

Language

English

ISBN 10

1574911279

ISBN 13

9781574911275

Binding

hardcover

Condition

New

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About this title

Synopsis

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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Justiniano, Jose; Gopalaswamy, Venky

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