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IVD Regulation and Software

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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Stefan Burde
Director Global Strategic Business Development IVD at TÜV SÜD
Speaker

Profile

Stefan Burde, PhD is the Director, Global Focus Team IVD at TÜV SÜD, a leading full-scope Notified Body under the European Medical Device and In Vitro Diagnostic Regulations (EU) 2017/745 and (EU) 2017/746. Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 9 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director. He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.

Agenda Sessions

  • Laboratory Developed Tests (LDTs): The Latest Regulation & You

    09:10
  • IVDs, Innovation and Industry: How Are We Shaping Up?

    08:40