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

✍ Scribed by G.R Higson (Author)

Publisher: CRC Press
Year: 2001
Leaves: 278
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ 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, en

✦ Table 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

✦ Subjects

Bioscience;General Science;Engineering & Technology;Biomedical Engineering;Physical Sciences;Physics;Medical Physics

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