G.R Higson
Medical Device Safety
The Regulation of Medical Devices for Public Health and Safety
Gebonden Engels 2001 9780750307680Levertijd ± 10 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
ISBN13:9780750307680
Taal:Engels
Bindwijze:Gebonden
Aantal pagina's:286
Uitgever:Taylor & Francis Ltd
Hoofdrubriek:Personeelsmanagement, Personeelsmanagement, Werk en loopbaan
Lezersrecensies
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Inhoudsopgave
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
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
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- advisering
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- it-management / ict
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- werk en loopbaan