December 20, 2017 IEC 60601-1 3rd Edition Risk Management

Manufacturers of medical devices have to evaluate and test their products according to IEC/EN/UL/60601-1. During the early design review or pre-compliance evaluation, understand the new requirement now a part of the 3rd edition of the 60601-1. Risk management activities have to be properly planned and prepared in accordance with the risk management process, so that risk and risk prevention can be evaluated and addressed.