2.2.2 System Safety – A Medical Perspective

Abstract

This paper examines safety aspects of medical devices such as: electronics, software, biological, toxicological, physiological, environmental, and even psychological factors. The views of different regulatory bodies in the world on approvals of medical devices are compared and contrasted. Examples of tradeoffs in design of medical devices and issues that face medical device engineers are presented. Risk assessment and mitigation techniques are discussed. Also, legal aspects of medical device safety are visited.