CEO - QUNIQUE GmbH
Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long 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 (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). 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) and their impact on the EU healthcare system.
1 blog from the author
Posted on 26.05.2021
MDR enters into full application and challenges remain
After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]