Practical Design Control Implementation for Medical Devices

by Jose Justiniano, Venky Gopalaswamy

Publisher: CRC
Publication Date: Wednesday, March 12, 2003
Number of Pages: 232
ISBN: 1574911279


Book Summary:

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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