Bassil Akra, Ph.D., is CEO of AKRA TEAM, a consultancy firm founded to support medical device companies, notified bodies and regulators in finding a practical and reasonable approach to fulfill their legal obligations. Prior to founding his firm, Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices. 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 Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR).