Practical Design Control Implementation for Medical Devices

Justiniano, Jose; Gopalaswamy, Venky

ISBN 10: 036739538X / ISBN 13: 9780367395384

Published by CRC Press, 2019

About this Item

pp. 232.

Seller Inventory # 379783531

Bibliographic Details

• Title: Practical Design Control Implementation for Medical Devices
• Publisher: CRC Press
• Publication Date: 2019
• Language: English
• ISBN 10: 036739538X
• ISBN 13: 9780367395384
• Binding: Soft cover
• Condition: New

About this title

Synopsis

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.

About the Author

Justiniano, Jose; Gopalaswamy, Venky