1st Edition

Practical Design Control Implementation for Medical Devices

By Jose Justiniano, Venky Gopalaswamy Copyright 2003
    232 Pages
    by CRC Press

    230 Pages 34 B/W Illustrations
    by CRC Press

    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