What is ISO 14971?

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.

http://youtu.be/YL7ZhIE4NAI

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