About the Book: 

Medical products and devices of all kinds need to comply witif regulations in order to satisfy the demand for public health and safety. Public awareness of the problems of assuring the safety of medical devices has been aroused in recent years by the failure of heart valves and breast implants and more effective regulatory methods are required. Combining the expertise of regulatory authorities world-wide offers a prospect of improvement in the control of such devices and in the time and effort involved in the regulatory procedures. 

This book reviews the development of safety regulation for medical devices from its relatively recent introduction in the 1960s to the present day. Landmark events in this process, notably the US Medical Device Amendments of 1976 and the EC Medical Devices Directive of 1994 are analysed and compared. An examination of the current regulations in the US, Europe and Japan, the three major markets for medical devices, leads to the identification of quality systems, product standards, effectiveness/performance and post-market controls as key factors in modern regulatory approaches. The emergence of these key factors illustrates the movement towards an engineering rather than the often traditional pharmaceutical approach to medical devices. 

Contents:

1. Introduction

2. The Transformation in the European Community

3. The Current Situation-The EC Medical Device Directive

4. The Current Situation-Regulations in USA and Japan

5. Comparison with The Medical Devices Directive

6. The Current Situation-Regulatory Developments in Other 

Countries

7. The Place of Quality Systems

8. The Use of Product Standards

9. The Question of Effectiveness

10. Post-Market Controls

11. Proposals and Prospects for A Global Regulatory System for Medical Devices

12. Overview and Look to The Future

About the Author: