If you are a medical device manufacturer, you can apply for a case study discussion. The selected manufacturer will receive a complimentary workshop registration and an independent assessment of their strategy to fulfill the new requirements.
*If you are interested in booking a hotel room for the night of October 18th, please contact Lisa VanDorpe.
Dr. Basil Akra
Global Focus Teams
Dr. Bassil Akra is the vice president of the global fo-cus teams (Cardiovascular, Orthopedic and Clinical) at TÜV SÜD Product Service. Dr. Akra has long ex-perience in research, development, quality manage-ment and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra is leading various consultation processes of medical devices incorporating an ancillary medicinal sub-stance with the different competent authorities desig-nated by the Member States or the EMA. As a senior field expert, he is presenting worldwide the require-ments in Europe and is involved in the development of several European guidance documents and stand-ards. He is member of the European Clinical Investi-gation and Evaluation working group and is repre-senting Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other Guidance Documents on In-novative Devices. Dr. Akra is member of the Europe-an task force on Safety Update Reporting.
Dr. Royth von Hahn
Vice President, Medical & Health Services
TÜV SÜD America
Dr. Royth von Hahn is the Global Director for Functional Safety, Software and Innovation of TÜV SÜD MHS Business Unit within the Product Service Division. He has been involved in several strategic projects within TÜV SÜD including business planning and implementation. Prior to his current role, he was product specialist for ultrasound devices and software and lead auditor for manufacturer certification. Before joining TÜV SÜD in 2007, he was co-founder of a MedTech start-up and an interim professor at a university of applied sciences. Dr. von Hahn holds a Masters degree in physics and industrial engineering as well as a PhD in electrical engineering.
Active Medical Products Audit Team Manager / Regional Program Manager for Functional Safety and Software
TUV SUD America
Adam Menzies serves dual roles at TÜV SÜD America as the Active Medical Products Audit Team Manager and the Regional Program Manager for Functional Safety and Software.
At TÜV SÜD America, Mr. Menzies is responsible for auditing and certification of a wide variety of active medical device companies according to international standards and regulations. As a member of the global focus team for functional safety and software, he also has expertise in medical device software safety, risk management and usability.
Prior to joining TÜV SÜD America in February 2016, Mr. Menzies served as Vice-President of Product Development for OrthoScan, a successful medical device startup based in Scottsdale, AZ. OrthoScan introduced CMOS flat detector technology to the mini c-arm market, and set the standard in dose minimization by developing viable pulsed-mode fluoroscopy using micro-focus x-ray generators.
Mr Menzies holds a B.Eng. (Hons.) in Electronics and Electrical Engineering from the University of Edinburgh, and is currently pursuing an MBA with specialism in Strategic Planning from Heriot-Watt University. He is a member of the IEEE Twin Cities chapter.
Norbert Stuiber, Dipl. Ing. (FH), MBA
Global Director, Sales & Strategic Marketing
TÜV SÜD Product Service GmbH, Medical & Health Services
Norbert is the Head of Sales & Strategic Marketing within the global division of Medical & Health Services. In his role, he oversees the challenges and trends in the medical device industry concerning global regulatory requirements. While at TÜV SÜD, Norbert has also worked as Lead Auditor and as an expert on global regulations for medical devices. Prior joining TÜV SÜD, he managed the business unit “automated infusion systems” for B. Braun. Norbert studied medical engineering and graduated with an MBA in Sales & Marketing.
Customer Service and Quality, Medical Health Services, TUV SUD America
Tamas Borsai is a Division Manager of Non-Active Medical Devices at TUV SUD America Inc. Tamas has over 20 years of experience in auditing medical devices manufacturers in the US, Europe and in Asia. In the past he held positions as lead auditor, technical certifier and country manager. Much of his technical expertise is focused on active medical devices as a graduated electric engineer and IT expert.