Medical Device 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.

G.R Higson

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