Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety, 1st Edition (e-Book) book cover

Medical Device Safety

The Regulation of Medical Devices for Public Health and Safety, 1st Edition

By G.R Higson

CRC Press

286 pages

Purchasing Options:$ = USD
Hardback: 9780750307680
pub: 2001-10-29
$275.00
x
eBook (VitalSource) : 9780429093036
pub: 2001-10-29
from $137.50


FREE Standard Shipping!

Description

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

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
SCI055000
SCIENCE / Physics
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical