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Bassil Akra
Vice President – Global Focus Teams (Cardiovascular, Orthopaedic and Clinical) at TÜV SÜD Product Service GmbH, Germany

Profile

Dr. Bassil Akra is the vice president of the global focus teams (Cardiovascular, Orthopedic, Active Implanta-ble, Aesthetic Devices and Clinical) at TÜV SÜD Prod-uct Service. Dr. Akra has long experience in research, development, quality management and regulatory ap-proval of medical devices, combination devices and ATMP products. Dr. Akra is leading various consulta-tion processes of medical devices incorporating an an-cillary medicinal substance with the different compe-tent authorities designated by the Member States or the EMA. As a senior field expert, he is presenting worldwide the requirements in Europe and is involved in the development of several European guidance doc-uments and standards. He is member of the European Clinical Investigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical require-ments such as MEDDEV and other Guidance Docu-ments on Innovative Devices. Dr. Akra is member of the German MDR Implementation Working Group, the NAKI. He is also member of the new MDR European task forces such as the one on PSUR, SSCP, Equiva-lence and sufficient clinical data.

Bassil Akra's Network

Agenda Sessions

  • Notified Body feedback: The EU Medical Device Regulation and preparing for implementation

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  • Notified Body feedback: The EU Medical Device Regulation and preparing for implementation

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  • DUAL DIALOGUE Legal Obligations and Relationship with your Notified Body

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  • NOTIFIED BODY PANEL DISCUSSION: An update on Notified Body designation: Scope, resource and timelines

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  • Notified Body expectations for clinical evaluations and investigations under the MDR

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  • Examining the implications of the MDR on data management: collection, triage, management and reuse of data for regulatory purposes

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