View On Demand Session

Duration: 1 hour, 7 minutes

Language: English

Cost: Free of charge

Target Group:
Product development professionals, quality managers, R&D professionals, design and compliance engineers and regulatory affairs professionals from medical equipment manufacturers

Content:
Overview of the high level changes to the 60601-1-2 standard, and the impact it will have on the testing and certification process for a Medical Device manufacturer.
Highlight what a manufacturer needs to be prepared for before they can start testing, especially the new role Risk Management and Essential Performance play in the testing process.

CSA Group’s Webinar on the new EMC Standard 60601-1-2 4th Edition prepares medical device manufacturers for the coming changes and answers important questions such as:

• What should be considered during product development?
• Which new requirements do I have to meet and what are the “highlights” of the updates?
• How is it different from the third edition of 60601-1-2?
• Which products are mostly affected by the new standard?
• What happens to existing certified products?
• What is the timeline for the changes with regard to accessing different markets such as North America or Europe?

View On Demand Session