MHS Workshop: Latest news on the European Medical Device Regulation
Save the Date for our upcoming workshop, Latest News on the European Medical Device Regulation!
This live, full day event includes technical information, Q&A and networking with TÜV SÜD experts.
Attendees will learn about the following:
Overview of the Medical Device Regulation (MDR)
Impact of the MDR on the conformity assessment process
Impact of the MDR on the technical documentation
New clinical and post-market surveillance requirements
Case study – Medical Device Manufacturer*
*Apply for an open case study session
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. To apply, please contact Lisa Van Dorpe.
*If you are interested in booking a hotel room for the night of April 30th, please contact Lisa Van Dorpe.
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.
TÜV SÜD Product Service GmbH, Munich
Martin Witte is a Global Director for TÜV SÜD Product Service GmbH, Munich since 2016. He started with TÜV SÜD as Product Specialist & Lead Auditor. Martin has held previous roles in Regulatory Affairs for BIOTRONIK SE & Co. KG, Berlin, as well as a role in Sales for BrainLAB Sales GmbH, Munich. In parallel to his position as Global Director he still acts as a Lead Auditor for the European Active Implantable Medical Devices Directive, ISO 13485 and acts furthermore as a Product Specialist for Active Medical Implants. Martin has a degree in Biomedical Engineering from the University of Applied Sciences Hamburg and additionally studied Information Technologies at Høgskolen I Agder, Norway.
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.