Medical device risk management

Abstract Medical device manufacturers are responsible for ensuring that their medical products are safe. Manufacturers and medical device users have an important role to play in maintaining the risk–benefit balance, by making sure that products are developed, tested, labeled, prescribed, and used in ways that maximum benefit and minimize risk. Medical device manufacturers must establish a risk management process that complies with ISO 14971 irrelevant of whether medical devices are being developed in the US, EU, Canada, or elsewhere. Every international regulatory agency accepts ISO 14971. There are several steps to the risk management cycle: risk analysis, risk evaluation, risk control, and residual risk acceptability. It is also useful after product launch to perform postmarket risk assessments and make decisions on whether field action is needed in case of the occurrence of an adverse event. This chapter describes a risk management process, overview of the risk management activities outlined in ISO 14971, a method for performing risk analysis using automated VBA (visual basic for applications—artificial intelligence). Risk control measures involve setting up the safety risk zone and mitigation. Finally, residual risk acceptability is usually revealed to the medical device user.