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MedTech Summit
16 - 20 June 2025
MOA BerlinBerlin, Germany

Marta Carnielli
Head of Certification IVD at TÜV SÜD Product Service GmbH
Speaker

Profile

Marta Carnielli works for TUV SUD as Head of Certification IVD; in this role, she is responsible for the certification process for IVD medical devices as well ensuring accreditations, designation and authorization relevant to IVDs are maintained by TUV Sud.

She is representing TÜV SÜD in regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group

Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department.

In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.

Agenda Sessions

  • Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop

    09:00
  • Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop

    14:10
  • Multi-Stakeholder Perspective: How the IVDR is Impacting Innovation & Industry

    16:15
  • IVDR Open Forum: Ask the Experts

    16:45
  • Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements

    08:55