Buch, Englisch, 286 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 599 g
The Regulation of Medical Devices for Public Health and Safety
Buch, Englisch, 286 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 599 g
ISBN: 978-0-7503-0768-0
Verlag: CRC Press
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.
Zielgruppe
Academic
Autoren/Hrsg.
Fachgebiete
- Wirtschaftswissenschaften Betriebswirtschaft Bereichsspezifisches Management Arbeitsplatz, Arbeitsschutz, Gefahrstoffschutz
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
- Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
Weitere Infos & Material
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
