ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis. This standardĀ helps guideĀ the process for medical device manufacturers to ensure that the product is safe.

Nick Oshman
Engineer, Sterling Medical Devices
Design, Develop, Test the Medical Devices of the Future