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Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

Paperback

Medical ReferenceChemistry

ISBN10: 036739538X
ISBN13: 9780367395384
Publisher: Crc Pr Inc
Published: Sep 25 2019
Pages: 232
Weight: 0.90
Height: 0.60 Width: 7.00 Depth: 9.90
Language: English
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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Medical Reference