eBook - ePub
Medical Device Safety
The Regulation of Medical Devices for Public Health and Safety
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- 286 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Book details
Table of contents
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About This Book
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, en
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Yes, you can access Medical Device Safety by G.R Higson in PDF and/or ePUB format, as well as other popular books in Medicine & Biotechnology in Medicine. We have over one million books available in our catalogue for you to explore.
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Table of contents
- Cover Page
- Half-Title Page
- Title Page
- Copyright Page
- Contents
- Preface
- Acknowledgments
- In memoriam
- Foreword
- 1 Introduction
- 2 The transformation in the European Community
- 3 The current situation: the EC Medical Devices Directive
- 4 The current situation: Regulations in USA and Japanâa comparison with the Medical Devices Directive
- 5 The current situation: regulatory developments in other countries
- 6 The place of quality systems
- 7 The use of product standards
- 8 The question of effectiveness
- 9 Key factorsâpost-market controls
- 10 Proposals and prospects for a global regulatory system for medical devices
- 11 Overview and look to the future
- Appendix 1 Practical steps towards global harmonization
- Appendix 2 Essential principles of safety and performance of medical devices
- Appendix 3 Role of standards in the assessment of medical devices
- Appendix 4 Adverse event reporting guidance for the medical device manufacturer or its authorized representative
- Appendix 5 Some useful web sites
- References
- Bibliography
- Index