CSA International Medical Device Series
IEC 60601-1, 3rd Edition and its Impact on the Certification Process for Test Houses and Manufacturers
This timely webinar series will provide an in-depth look into the most important changes of the IEC 60601-3, 3rd Edition and its impact on the design and certification process. Our facilitator will provide steps and processes of how and what a Test House will require to certify Medical Electrical Equipment according to the new Standard.
Session Objectives:- Application of 14971 Safety Risk Management as per the adopted IEX 60601-1, 3rd Edition
- Regulatory documentation requirements for North American and European certification according to the adopted 60601-1, 3rd Edition