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Practical Design Control Implementation for Medical Devices PDF

230 Pages·2003·3.807 MB·English
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by Jose Justiniano, Venky Gopalaswamy| 2003| 230 pages| 3.807| English

About Practical Design Control Implementation for Medical Devices

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.

Detailed Information

Author:Jose Justiniano, Venky Gopalaswamy
Publication Year:2003
ISBN:9780203010716
Pages:230
Language:English
File Size:3.807
Format:PDF
Price:FREE
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