Challenges with EU MDR/IVDR UDI Implementation

,
Webinar

Challenges with EU MDR/IVDR UDI Implementation

Werfen Sie mit einem der Pioniere des UDI-Systems, Jay Crowley, einen Blick auf die Umsetzung von UDI in Europa (Webinarsprache: Englisch).

Inhalt / Content

As the MDR Date of Application approached, challenges continue with understanding how UDI implementation will happen. In this webinar, we will cover how UDI will apply to various device types (including software and accessories), how Basic UDI-DI will work, and what types of device registration and UDI data will be submitted to Eudamed. We will also cover other areas where UDI will be used.

Nutzen

After the webinar you will understand more and better the challenges resulting for UDI and how to solve them.

Zielgruppe

Verantwortliche und Fachkräfte von Medizinprodukte- und Medizintechnikherstellern, die an der Umsetzung der UDI Anforderungen beteiligt sind, aus den Funktionsbereichen:

  • Qualitätssicherung
  • Logistik
  • IT
  • Export
Mehr zu Jay Crowley

Jay Crowley is currently Vice President, UDI Solutions and Services, at USDM Life Sciences. Prior to joining the firm in January 2014, Crowley was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health.  He held a variety of positions over his nearly 27 years at FDA.  Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.