MedDev Day

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. 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 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), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.

Daniel Delfosse, Dr.sc.techn., is Vice-Director and Head of Regulation & Innovation at the industry association Swiss Medtech. His mantra is “innovation despite regulation” and he pursues the goal of keeping Switzerland an attractive location for the medtech industry.
Daniel graduated from ETH Zurich as a materials engineer and did his doctorate at EPF Lausanne. After a research stay at the University of British Columbia in Vancouver, Canada, he moved to the medtech industry. For almost 20 years he worked as head of development and member of the executive board for a Swiss orthopaedics company, always at the crossroads between regulation and innovation

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs of MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria.
Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function which has global responsibility for product licensing, registrations, re-certifications, post-market vigilance activities, regulatory strategies for new product developments and related compliance activities internally within MED-EL and externally to new and changed regulations and standards.

William Lory, Pharm. D. is Regulatory Affairs Manager EMEA at Sirtex Medical whose mission is to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 10+ years of experience in medical device regulatory affairs with multiple submissions at global scale and more specifically according to the Medical Device Regulation (EU) 2017/745.

Amra is the Sr. Director of Global Government Strategy for MedTech at Veeva Systems. She has been in the Healthcare Industry for over 23 years, and most of those spent in large medical device companies in a variety of regulatory roles. In addition to Abbott and Bayer, she spent 13 years at Medtronic working on global regulatory advocacy, global strategy and global regulatory intelligence, which allowed her to represent the organization in a number of external working groups and hold various chair, co-chair and SME roles. In addition to her day job, she finds time to teach International Regulatory at a local University in MN and also serves on the board of a non-profit called WISE (Women initiatives for self empowerment) focused on ensuring young women in underserved and immigrant communities understand healthy relationships and have opportunities to finish schooling.

Biography available soon