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

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.

List of contents

PREFACE
ACKNOWLEDGMENTS
FOREWORD

INTRODUCTION

THE TRANSFORMATION IN THE EUROPEAN COMMUNITY

THE CURRENT SITUATION-THE EC MEDICAL DEVICE DIRECTIVE

THE CURRENT SITUATION-REGULATIONS IN USA AND JAPAN
A Comparison with the Medical Devices Directive

THE CURRENT SITUATION-REGULATORY DEVELOPMENTS IN OTHER COUNTRIES

THE PLACE OF QUALITY SYSTEMS

THE USE OF PRODUCT STANDARDS

THE QUESTION OF EFFECTIVENESS

POST-MARKET CONTROLS

PROPOSALS AND PROSPECTS FOR A GLOBAL REGULATORY SYSTEM FOR MEDICAL DEVICES

OVERVIEW AND LOOK TO THE FUTURE

APPENDICES
REFERENCES
BIBLIOGRAPHY

About the author

G.R Higson

Product details

• Authors: G. R Higson, G.R Higson
• Publisher: Taylor and Francis
• Languages: English
• Product format: Hardback
• Released: 29.10.2001
• EAN: 9780750307680
• ISBN: 978-0-7503-0768-0
• No. of pages: 286
• Weight: 660 g
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Clinical medicine; Social sciences, law, business > Sociology > Labour, economic and industrial sociology; TECHNOLOGY & ENGINEERING / Industrial Health & Safety, MEDICAL / Instruments & Supplies, Medical equipment & techniques, BUSINESS & ECONOMICS / Labor / General, Health & safety issues, Health and safety in the workplace, Medical equipment and techniques