ABSTRACT

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

chapter 1|7 pages

Introduction

chapter 6|19 pages

The place of quality systems

chapter 7|20 pages

The use of product standards

chapter 8|20 pages

The question of effectiveness

chapter 9|14 pages

Key factors—post-market controls

chapter 11|10 pages

Overview and look to the future