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.
By:
Jose Justiniano, Venky Gopalaswamy Imprint: CRC Press Country of Publication: United Kingdom Dimensions:
Height: 254mm,
Width: 178mm,
Weight: 453g ISBN:9780367395384 ISBN 10: 036739538X Pages: 232 Publication Date:25 September 2019 Audience:
Professional and scholarly
,
Undergraduate
Format:Paperback Publisher's Status: Active
