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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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About the Author
Justiniano, Jose; Gopalaswamy, Venky
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Practical Design Control Implementation for Medical Devices
Published by
Taylor & Francis Ltd, 2019
ISBN 10: 036739538X
ISBN 13: 9780367395384
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Practical Design Control Implementation for Medical Devices
Published by
Taylor & Francis Ltd, 2019
ISBN 10: 036739538X
ISBN 13: 9780367395384
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