Medical Device Safety

The Regulation of Medical Devices for Public Health and Safety

G.R Higson

• Publisher: CRC Press
• Year: 2001
• Print ISBN: 9780750307680
• eBook ISBN: 9781040053935
• Edition: 1
• Topic: Médecine
• Subtopic: Physique

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, en

Table of contents

• Cover Page
• Half-Title Page
• Title Page
• Copyright Page
• Contents
• Preface
• Acknowledgments
• In memoriam
• Foreword
• 1 Introduction
• 2 The transformation in the European Community
• 3 The current situation: the EC Medical Devices Directive
• 4 The current situation: Regulations in USA and Japan—a comparison with the Medical Devices Directive
• 5 The current situation: regulatory developments in other countries
• 6 The place of quality systems
• 7 The use of product standards
• 8 The question of effectiveness
• 9 Key factors—post-market controls
• 10 Proposals and prospects for a global regulatory system for medical devices
• 11 Overview and look to the future
• Appendix 1 Practical steps towards global harmonization
• Appendix 2 Essential principles of safety and performance of medical devices
• Appendix 3 Role of standards in the assessment of medical devices
• Appendix 4 Adverse event reporting guidance for the medical device manufacturer or its authorized representative
• Appendix 5 Some useful web sites
• References
• Bibliography
• Index