Head of Certification IVD at TuV Sud
TUV Sud GmbH, Germany
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.
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Wednesday, May 10, 2023
16:30 – 18:30 CEST
Conformity Assessment of Class D Devices: What is the Current Status?
Thursday, May 11, 2023
16:45 – 17:45 CEST
Conversations That Matter: Interactions with Health Authorities
Friday, May 12, 2023
08:45 – 10:00 CEST
Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
Friday, May 12, 2023
10:45 – 11:45 CEST
MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
Friday, May 12, 2023
15:30 – 16:30 CEST