Practical Design Control Implementation for Medical Devices: 1st Edition (Paperback) book cover

Practical Design Control Implementation for Medical Devices

1st Edition

By Jose Justiniano, Venky Gopalaswamy

CRC Press

232 pages

Purchasing Options:$ = USD
Paperback: 9780367395384
pub: 2019-09-25
$74.95
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Hardback: 9781574911275
pub: 2003-03-12
$180.00
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eBook (VitalSource) : 9780429214752
pub: 2003-03-12
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Description

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.

Table of Contents

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 Authors

Justiniano, Jose; Gopalaswamy, Venky

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General
TEC009070
TECHNOLOGY & ENGINEERING / Mechanical
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical