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MedTech Summit
16 - 20 June 2025
MOA BerlinBerlin, Germany

Nebojsa Serafimovic
Assessor for Clinical Investigations at Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
Advisor

Profile

Mr Nebojsa Serafimovic is an assessor for clinical investigations with medical devices and performance evaluations with in vitro diagnostics at the AGES/BASG. Besides approving studies he is involved in the development of national processes to tackle MDR and IVDR requirements. Prior to his work at the Competent Authority, Nebo worked for Philips Austria in the field of medical device engineering and the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM in Vienna. Nebo is member of the Clinical Investigation and Evaluation Working Group and contributes in a number of taskforces.

Agenda Sessions

  • Current European Development: Clinical Evaluations & Investigations under EU MDR

    08:50
  • 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