G.R Higson

Medical Device Safety

The Regulation of Medical Devices for Public Health and Safety

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis Ltd
• Seitenzahl: 288
• Erscheinungstermin: 29. Oktober 2001
• Englisch
• Abmessung: 240mm x 161mm x 20mm
• Gewicht: 590g
• ISBN-13: 9780750307680
• ISBN-10: 0750307684
• Artikelnr.: 22347616

Autorenporträt

G.R Higson

Inhaltsangabe

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