Practical Design Control Implementation for Medical Devices
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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Practical Design Control Implementation for Medical Devices
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.
240.0 In Stock
Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

Hardcover(Revised ed.)

$240.00 
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Overview

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.

Product Details

ISBN-13: 9781574911275
Publisher: Taylor & Francis
Publication date: 03/12/2003
Edition description: Revised ed.
Pages: 230
Product dimensions: 7.30(w) x 10.10(h) x 0.70(d)

About the Author

Justiniano, Jose; Gopalaswamy, Venky

Table of Contents

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