On September 2, IAS and the U.S. Commercial Service Germany  is organizing a virtual event together with the California-based International Accreditation Service on the topic of "Accreditation of International Testing Bodies for Product Approvals on the American Market". 

Medical devices and products have a direct impact on public health and safety. Therefore, it's crucial to be able to prove the highest level of safety and good quality through accreditation. This event will provide important information for German testing laboratories and European medical device manufacturers about the U.S. Food and Drug Administration (U.S. FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

The voluntary program which recognizes accredited testing laboratories is designed to help make medical device and in vitro diagnostic product (IVD) premarket reviews more consistent and efficient. The FDA also intends for the program to reduce the regulatory burden on device manufacturers by increasing product reviewers’ trust in medical device testing. Join our free webinar to learn more about the accreditation requirements, the new FDA ASCA program and IAS as an FDA approved accreditation body.

 Event Highlights

 • Introduction by the U.S. Commercial Service in Germany

 • U.S. FDA Background & Expectations for ASCA

 • IAS Overview about Laboratory Accreditation Process 

• Underwriters Laboratories Accreditation Experience

 • Frequently Asked Questions 

Interested to participate in the webinar? Please reach out to Nikolay and Magdalena for an additional information.

Nikolay Tretyakov
Project Manager International Business
nikolay.tretyakov@sibb.de

Magdalena Zawodny-Barabanow
Project Manager International Business
magdalena.zawodny-barabanow@sibb.de