Bonn, March 13th 2023
On the agenda are important topics such as IEC 60601 Renewal 2, the standard for the performance for medical equipment with regard to electromagnetic (EM) disturbances associated with electromagnetic compatibility (EMC) emissions and immunity, and the accompanying serious changes that affect many medical devices.
Aspects, standards and challenges of home healthcare, which are becoming an increasingly important area, will also be discussed, as well as the current revisions to ISO 10993, the biological evaluation of medical devices, and its contents, which are of paramount importance to anyone involved in toxicological risk assessment.
“The growing complexity of medical electrical devices requires more advanced testing and certification to evaluate compliance to safety and performance requirements,” said Alex Martin-Smith, senior medical product specialist in the Consumer, Medical Information and Technology group at UL Solutions. “We are excited to join GHA and share insight on navigating requirements across different regions and on the latest requirements to bring medical devices to market.”
UL Solutions is a long-standing GHA – German Health Alliance member and a global leader in applied safety science. The company transforms safety and sustainability challenges into opportunities for businesses in more than 100 countries.
Erhard Fichtner, CEO of GHA said, “High-end German medical technology needs partner companies like UL Solutions to help get their products and services well through the increasingly lengthy development and approval processes.”
UL Solutions provides testing, inspection and certification services, software products, and advisory services that specifically support product innovation and business growth for companies in the industry. UL certification marks are a recognized symbol of trust in their customer’s products.
The digital webinar will be held in English on March 21, 2023, starting at 10h. Registrations for complimentary participation are available online on the GHA website.