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MedTech Summit

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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Bassil Akra
CEO at AKRA TEAM GmbH
Advisor

Profile

Dr. Bassil Akra is CEO and Owner of AKRA TEAM, a globally acting consultancy company with the headquarter in Germany. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.

Agenda Sessions

  • Multi-Stakeholder Perspective: The Impact of the MDR on Innovation & Industry

    16:45
  • Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations

    08:45
  • Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations

    14:10
  • Best Practices in Enterprise Evidence Management

    14:15
  • Decoding Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performances (SSCPs)

    14:15
  • Ask the Experts – Clinical Evaluations & Investigations and Post-Market Surveillance

    16:15