Practical Design Control Implementation for Medical Devices

✍ Scribed by Jose Justiniano, Venky Gopalaswamy

• Publisher: Informa Healthcare
• Year: 2003
• Tongue: English
• Leaves: 230
• Edition: 1
• Category: Library

✦ 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.

✦ Table of Contents

BOOK COVER......Page 1
TITLE......Page 2
COPYRIGHT......Page 3
CONTENTS......Page 4
PART ONE Practical Design Control Implementation......Page 8
INTRODUCTION......Page 10
CHAPTER ONE Motivation for Design Control and Validation......Page 16
CHAPTER TWO Design Control Requirements......Page 24
CHAPTER THREE Design Transfer and Process Validation......Page 66
CHAPTER FOUR Quality System for Design Control......Page 98
CHAPTER FIVE Measuring Design Control Program Effectiveness......Page 116
PART TWO Medical Device Reliability......Page 120
CHAPTER SIX Medical Device Reliability Overview......Page 122
CHAPTER SEVEN Reliability Plan......Page 130
CHAPTER EIGHT Risk Analysis and FMEA......Page 140
CHAPTER NINE Designing-In Reliability......Page 162
CHAPTER TEN Reliability and Design Verification......Page 182
CHAPTER ELEVEN Reliability and Design Validation......Page 198
CONCLUSION......Page 202
ACRONYMS AND DEFINITIONS......Page 204
REFERENCES......Page 210
INDEX......Page 214

✦ Subjects

Медицинские дисциплины;Медицинские приборы и аппараты;