Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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