Medical Device Safety

The Regulation of Medical Devices for Public Health and Safety

G.R Higson (Autor)

Buch | Hardcover

286 Seiten

2001
Institute of Physics Publishing (Verlag)
978-0-7503-0768-0 (ISBN)

Artikel merken

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

Erscheint lt. Verlag	29.10.2001
Verlagsort	London
Sprache	englisch
Maße	156 x 234 mm
Gewicht	612 g
Themenwelt	Medizin / Pharmazie
	Technik ► Medizintechnik
	Wirtschaft
ISBN-10	0-7503-0768-4 / 0750307684
ISBN-13	978-0-7503-0768-0 / 9780750307680
Zustand	Neuware