Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety

✍ Scribed by G.R Higson

• Year: 2002
• Tongue: English
• Leaves: 286
• Edition: 1
• Category: Library

✦ Synopsis

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.

✦ Table of Contents

Contents......Page 5
Preface......Page 7
Acknowledgments......Page 9
In memoriam......Page 11
Foreword......Page 13
1. Introduction......Page 15
2. The transformation in the European Community......Page 22
3. The current situation: the EC Medical Devices Directive......Page 46
4. The current situation: Regulations in USA and Japan—a comparison with the Medical Devices Directive......Page 86
5. The current situation: regulatory developments in other countries......Page 109
6. The place of quality systems......Page 123
7. The use of product standards......Page 142
8. The question of effectiveness......Page 162
9. Key factors—post-market controls......Page 182
10. Proposals and prospects for a global regulatory system for medical devices......Page 196
11. Overview and look to the future......Page 208
Appendix 1......Page 218
Appendix 2......Page 223
Appendix 3......Page 233
Appendix 4......Page 239
Appendix 5......Page 250
References......Page 253
Bibliography......Page 274
Index......Page 277