Safety & hazard analysis for software controlled medical devices

Advanced medical devices are progressively more controlled by software. In many cases software plays a central role in the safety critical devices. Historically, the question of safety has received more attention with respect to hardware than software. However, software can also make a significant contribution to the safeness of a device. In this paper device safety is examined in a system context. Since the study of software safety is relatively new, at first the nature of software failures is examined. This is followed by touching on the vocabulary of safety analysis. Some methods of analysis, detection, control and containment of hazards are described and some good practices for developing safe medical devices are suggested