Webinar - New IEC 60601-1 3rd ed. Amendment
Service Detail from CSA Group Testing and Certification Inc.
Are you ready to meet the new IEC 60601-1 Amendment 2 requirements?
Medical device standards are updated often. This can make it difficult for medical device manufacturers to keep up with the latest changes impacting their technical documentation, product development schedules, and time to market.
Hosted by a certification expert, this one-hour webinar will walk you through:
- Changes to process standards and how they affect IEC 60601-1 evaluation
- Major changes to ISO 14971:2019 from the prior edition
- Usability Engineering process IEC 62366-1:2015 compliance
- Software development process IEC 62304:2006/62304:2006/Amd. 1:2015 compliance
- Major changes to the medical electrical equipment general IEC 60601-1 standard
- Changes to alarms standard IEC 60601-1-8