1st Edition
Practical Design Control Implementation for Medical Devices
232 Pages
by
CRC Press
230 Pages
34 B/W Illustrations
by
CRC Press
232 Pages
by
CRC Press
Also available as eBook on:
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.
PART ONE Practical Design Control Implementation, PART TWO Medical Device Reliability, Conclusion, Acronyms and Definitions, References
Biography
Justiniano, Jose; Gopalaswamy, Venky