Medical device safety : the regulation of medical devices for public health and safety
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Gordon R Higson
- ناشر : Bristol : Institute of Physics
- چاپ و سال / کشور: 2002
- شابک / ISBN : 9780750307680
Description
Contents Preface vii Acknowledgments ix In memoriam xi Foreword xiii 1 Introduction 1 2 The transformation in the European Community 8 3 The current situation: the EC Medical Devices Directive 32 4 The current situation: Regulations in USA and Japan— a comparison with the Medical Devices Directive 72 5 The current situation: regulatory developments in other countries 95 6 The place of quality systems 109 7 The use of product standards 128 8 The question of effectiveness 148 9 Key factors—post-market controls 168 10 Proposals and prospects for a global regulatory system for medical devices 182 v 11 Overview and look to the future 194 Appendix 1 Practical steps towards global harmonization 204 Appendix 2 Essential principles of safety and performance of medical devices 209 Appendix 3 Role of standards in the assessment of medical devices 219 Appendix 4 Adverse event reporting guidance for the medical device manufacturer or its authorized representative 225 Appendix 5 Some useful web sites 236 References 239 Bibliography 260 Index 263
