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 quality systems and technical documentation, product development schedules, and time to market.
Join us on September 21 at 10 am EST to learn about the latest changes to IEC 60601-1.
Hosted by a certification expert, this one hour webinar will walk you through:
• Changes to process standards and how they affect IEC 60601-1 evaluations
• Major changes to ISO 14971:2019 from prior editions
• 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 standard
• Changes to alarms standard IEC 60601-1-8
Don't miss this opportunity to speak directly with a technical expert.
Technical Training Specialist
Vamsee Patta is a Technical Training Specialist with CSA Group’s Medical Product Group. He develops and delivers technical training to Medical Certifiers/Engineers at CSA Group and to external clients. Vamsee also plays a key role in developing training for new standards and certification programs for the Medical Product Group.
Over the course of his tenure at CSA Group, he has been evaluating a wide variety of medical products to IEC 60601-1 and its various collateral and particular standards.
Key Learning Objectives
Changes to process standards and how they affect IEC 60601-1 evaluations
Major changes to ISO 14971:2019 from prior editions
Major changes to the medical electrical equipment general standard
Software development process IEC 62304:2006/62304:2006/Amd. 1:2015 compliance