Martin Witte is Senior Director Strategic Business Development for the Medical Health Service business at TÜV SÜD and responsible for strategic topics such as Active Medical Implants, Cardiovascular, Orthopaedic, and Functional Safety/Software.

Prior to his current role, Martin was a Lead Auditor and Product Specialist for high-risk devices. Prior to TÜV SÜD, Martin worked on the industry side for 6 years as a Regulatory Affairs Manager with BIOTRONIK, focusing on heart rhythm management devices and MRI safety of active implantable devices. Martin is a strong supporter of digitalization in the Medtech world.

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Frank Matzek serves as the Vice President Regulatory & Governmental Affairs at BIOTRONIK in Berlin, Germany. BIOTRONIK is a leading global medical device com­pany with products and services that save and improve the lives of patients suffering from cardiovascular and endovascular diseases.

Frank holds a Dipl.-Ing. degree in biomedical engineering from the Technical Univer­sity of Berlin, is a certified quality engineer and has received a degree in business and administration from VWA Berlin.

In addition to his role with BIOTRONIK, Frank is actively involved in the industry associations MedTech Europe and BVMed Germany as a member/vice-chair of various core teams, work groups and committees.

Dr. Bassil Akra is CEO and one of the owners of the 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.

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs of MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria.

MED-EL is the global innovation leader in hearing loss solutions. To date, MED-EL’s implantable and non-implantable systems marketed in over 140 markets have restored hearing to more than 200,000 individuals worldwide.

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.

She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities. Previously Elizabeth worked in the mobile telecommunications sector in regulatory compliance and data protection in Vodafone Ireland. Her educational background is in social sciences, with her graduate and post graduate studies in Sociology completed at the University of the Witwatersrand, South Africa where she was active for many years as a lecturer and social researcher.

Kim is an Experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Kim has industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators, and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation. 

Kim is a recognized international expert in global medical device regulations, wrote and harmonized the US FDA Quality System Regulation 21 CFR § 820, and was on the international authoring group of ISO 13485 since inception. While at the US FDA conceived and developed the MDSAP international consortium of five Global Regulators, as well as its many foundational documents. She is a twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF). Also a Medical Device expert on the Center for Drug Evaluation and Research (CDER) "GMPs for the 21st Century Initiative" Steering Committee and on the FDA authoring group for the Combination Product Good Manufacturing Practice (GMP) Part 4 regulation. Kim's last position at CDRH was Associate Director for International Affairs within the Office of the Director. Currently, at NSF International in the Health Sciences Division, Kim is leveraging her over thirty years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International global clients.

Marcia Orozco is an Associate Director of MDR & Safety Operations in the Global Medical Safety group for Alcon. She holds a Master’s degree in Biomedical Engineering from the University of Miami. She started her ca­reer at Innovia LLC in their Research and Development department supporting new product development of ophthalmic and cardiovascular medical devices. She later transitioned to Alcon/Novartis in their Global Device Medical Safety group, where she supported clinical trials and risk management for the surgical and vision care franchises. She transitioned into the MDR leader role while participating in Alcon’s EU MDR initiative. In this role she has implemented tools and procedures to comply with the EU MDR safety reports for all Alcon products.

Specialized in EU regulatory issues relating to medical devices, including eHealth, mHealth and protection of personal data. Active in law and policy development as a committee member of branch associations and the European Commission.  

Axon lawyers focused on legal and regulatory aspects on the life sciences sector. 

Paul is a Senior Manager Regulatory Consulting at Deloitte Netherlands with an industry focus on Life Sciences & Health Care. He has 4 years of biomedical research experience and 10 years of industry experience in delivering regulatory compliance, remediation, and transformation projects covering a wide range of medical devices and technologies, including in-depth knowledge of the Medical Device Regulation across the device lifecycle. Paul is an auditor ISO 13485:2016, and he further supports the life sciences industry and regulators with their regulatory policy and with keeping up with the evolving regulatory landscape.