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Synopsis
-- 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.
Readership: Medical device
manufacturers & legislators; MSc/PhD
students in biomedical engineering
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Table Of Contents
Preface vii
Acknowledgments ix
In memoriam xi
Foreword xiii
Introduction
1 (7)
The transformation in the European
Community
8 (24)
The current situation: the EC
Medical Devices Directive
32 (40)
The current situation: Regulations
in USA and Japan---a comparison with
the Medical Devices Directive
72 (23)
The current situation: regulatory
developments in other countries
95 (14)
The place of quality systems
109 (19)
The use of product standards
128 (20)
The question of effectiveness
148 (20)
Key factors---post-market controls
168 (14)
Proposals and prospects for a global
regulatory system for medical
devices
182 (12)
Overview and look to the future
194 (10)
Appendix 1 Practical steps towards
global harmonization 204 (5)
Appendix 2 Essential principles of
safety and performance of medical
devices 209 (10)
Appendix 3 Role of standards in the
assessment of medical devices 219
(6)
Appendix 4 Adverse event reporting
guidance for the medical device
manufacturer or its authorized
representative 225 (11)
Appendix 5 Some useful web sites 236
(3)
References 239 (21)
Bibliography 260 (3)
Index
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