Dr. Bassil Akra is the global director of the clinical centre of excellence at TÜV SÜD Product Service GmbH. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra is leading various consultation processes of medical device incorporating an ancillary medicinal substance with the different competent authorities that are designated by the Member States or the EMA. He is presenting as a senior expert worldwide the requirements in Europe and is involved in the development of several European guidance documents 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 requirements such as the new MEDDEV and the Guidance Documents on Innovative Devices.