Practical Design Control Implementation for Medical Devices

Justiniano, Jose; Gopalaswamy, Venky

ISBN 10: 1574911279 ISBN 13: 9781574911275

Editorial: CRC Press (edition 1), 2003

Idioma: Ingl�s

Condici�n: Usado - Aceptable Encuadernaci�n de tapa dura

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Detalles bibliogr�ficos

T�tulo: Practical Design Control Implementation for Medical Devices
Editor: CRC Press (edition 1)
Fecha de publicaci�n: 2003
Idioma: Ingl�s
ISBN 10: 1574911279
ISBN 13: 9781574911275
Encuadernaci�n: Hardcover
Edici�n: 1.
Estado: Good

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Sinopsis

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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