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Practical Design Control Implementation for Medical Devices
Udgivet af Taylor & Francis Ltd
ISBN
9780367395384
Om denne bog
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…
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Bogdetaljer
Forfatter
Jose Justiniano, Venky Gopalaswamy
Forlag
Taylor & Francis Ltd
Kategori
Produktionsindustri
ISBN-13
9780367395384
EAN
9780367395384
Format
Hæftet
Sprog
Engelsk
sider
232
Produktbeskrivelse
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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