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Thursday, 15 October 2026 | 13:20 - 14:35

B3: MDR inspections and audits: Learning from the regulator’s, notified body’s, and industry’s perspectives

Location:Room 8: Sophie
  • 13:20: Anja Buchberger: BASG Inspections - Structure, Process, and Common Findings
  • 13:45: Thomas Schuhmacher: MDR Assessment and Audits - Insights from the Notified Body's Perspective
  • 14:10: Valentin Schwarz: 15+ Audits in 3 Years: Lessons Learned from a Small Medical Device Manufacturer

3 speakers

  • Medical Device Inspector

    AGES/BASG

  • Lead auditor, senior product specialist and customer relationship manager

    TÜV SÜD Product Service GmbH

  • Head of R&D/QM and PRRC

    Biegler GmbH