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Practical design control implementation for medical devices

Author: Jose M Justiniano; Venky Gopalaswamy
Publisher: Boca Raton : Interpharm/CRC, ©2003.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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,  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Justiniano, Jose M.
Practical design control implementation for medical devices.
Boca Raton : Interpharm/CRC, ©2003
(DLC) 2002013391
(OCoLC)50511504
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Jose M Justiniano; Venky Gopalaswamy
ISBN: 1574911279 9781574911275 020301071X 9780203010716
OCLC Number: 228141372
Description: 1 online resource (v, 223 pages) : illustrations
Contents: Motivation for design control and validation --
Design control requirements --
Design transfer and process validation --
Quality system for design control --
Measuring design control program effectiveness --
Medical device reliability overview --
Reliability plan --
Risk analysis and FMEA --
Designing-in reliability --
Reliability and design verification --
Reliability and design validation.
Responsibility: Jose M. Justiniano, Venky Gopalaswamy.

Abstract:

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 verific.

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