Risk Management and Third Edition

05 September 2011

Third Edition IEC 60601-1 has a continued impact on manufacturers of medical devices. Specifically, this standard is different from the second edition in that it now adds a risk management factor that all manufacturers and certifying bodies must comply.

There is an increased element of risk management in this standard because it is strategically integrated throughout its entirety. Manufacturers now have to implement a risk management process and recognize ways to determine risk acceptance in accordance with ISO 14971.

Todd Konieczny, North American Medical Technical Leader for Intertek can further address questions around this subject.

To learn more about Third Edition and risk management or to speak with Todd or another Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com