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
Summary
-- Examines the development and present state of safety regulations for medical devices world wide.-- Written for graduate students and professionals in biomedical engineering and medical physics, especially those concerned with device development.-- Major market will be industrial, i.e. device manufacturers.-- Gordon Higson is regarded as the key opinion leader in the area of global regulatory harmonisation and a founder member of the Global Harmonisation Task Force.-- No present competition.<p/>Readership: Medical device manufacturers & legislators; MSc/PhD students in biomedical engineering
Bibliography
Includes bibliographical references (pages 260-262) and index
Notes
Description based on online resource; title from PDF title page (viewed May 11, 2022)
