This paper starts with a brief overview of the development of risk management over the past centuries, from elementary risk awareness in the early days to the structured stepwise process of planning, assessment, control and monitoring that we have today. This includes a review of how regulations and standards for medical devices have developed over the recent decades. The risk management process as described in BS EN ISO 14971 is discussed in detail and the main changes in the third edition are indicated and explained. The broader context of BS EN ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements is also discussed.
Risk management for medical devices and the new BS EN ISO 14971
