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Practical Design Control Implementation for Medical Devices

Autor Jose Justiniano, Venky Gopalaswamy
en Limba Engleză Paperback – 25 sep 2019
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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Specificații

ISBN-13: 9780367395384
ISBN-10: 036739538X
Pagini: 232
Dimensiuni: 178 x 254 x 15 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Academic and Professional Practice & Development

Notă biografică

Justiniano, Jose; Gopalaswamy, Venky

Cuprins

PART ONE Practical Design Control Implementation, PART TWO Medical Device Reliability, Conclusion, Acronyms and Definitions, References

Descriere

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.