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 standard helps guide the process for medical device manufacturers to ensure that the product is safe.
by Nick Oshman
Director of Quality Assurance, Sterling Medical Devices
Design, Develop, and Test the Medical Devices of the Future