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.

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.

Leon Doorn boasts over 15 years of hands-on experience in the global medical device industry, having held various positions in Quality, Regulatory, and Information Security. He brings rich experience in the medical device consulting field, having supported start-ups, medium-sized, and large enterprises primarily in high-risk medical devices and AI-enabled Software as Stand-alone Medical Devices (SAMDs). He loves sharing his domain knowledge through blogs, providing valuable insights to readers.

Jacqueline van Druten (MICR.CIM.RD) is a healthcare professional with extensive experience in Clinical Regulatory Affairs. With a passion for MedTech, Jacqueline has been a driving force building CLIN-r+ EU MDR submissions automation and fast track Clinical Development Strategy workflow for EU MDR submissions for Med Tech manufacturers. Her expertise is backed by 20 years of hands-on experience in healthcare research and medical innovations. As a contributor and lead in Research, Regulatory and Clinical Affairs at various multi-national medical organisations, Jacqueline has been instrumental in supporting the translation of medical interventions into measurable patient outcome data. Enabling healthcare innovations obtain regulatory clearance, market access and product differentiation to meet their investment promise. Her career and team contributions have a proven track record of success in obtaining EU MDR CE marking in various product classes, demonstrating their deep understanding of obtaining a successful innovation profile for commercial, clinical benefit and regulatory compliance. As the Clinical & Regulatory Affairs Director at CLIN-r+, she leads a team of consultants and advisors who provide data-driven solutions for medical device regulation (compiling Technical Document), clinical development strategies (CDP) clinical evaluations (CEP and CER) , and post-market surveillance (PSUR,SSCP and PMSR) for MedTech customers. With over two decades of experience in the healthcare industry, she has a strong background in clinical research, medical innovation (pharma, MedTech, biotech and nutraceuticals) and marketing, as well as a particular interest in MedTech validations, MedTech sustainability assessments, paediatrics, neonatology, gastroenterology, and critical care.

Wiebe Postma is a highly skilled clinical research professional with a PhD in Biology and over 12 years of experience in the medical device industry. With a robust background in regulatory and clinical roles, Wiebe has extensive expertise in clinical evaluation, including the development and assessment of Clinical Development Plans (CDP), Clinical Evaluation Plans (CEP), and Clinical Evaluation Reports (CER). He is proficient in clinical investigation processes, encompassing medical writing, Clinical Investigation Plan (CIP) development, study management, site management, and monitoring.

Wiebe has significant experience in post-market surveillance (PMS) and post-market clinical follow-up (PMCF), ensuring compliance with EU MDR, ISO 14155 GCP, MEDDEV 2.7/1, ISO 14971, and ISO 13485 standards. He has worked with a wide range of medical devices, including Class I-III and implants, and possesses extensive auditing experience, KOL engagement, and a broad range of skills within Medical Affairs, Clinical Affairs, Regulatory Affairs, and Compliance.

As partner of our life sciences practice, Fabien Roy focusses his practice at Hogan Lovells on advising clients on European Union and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. Fabien follows the new regulations on medical devices (MDR and IVDR) and the GDPR very closely and regularly advises clients on the requirements applicable to their digital health technologies. With a practice entirely focusing on complex regulatory issues faced by life sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling clients to focus on their business.

Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device clients. Fabien also assists life sciences clients in the preparation, drafting, and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European authorised representative agreements, and distribution agreements.

She gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Youth and Healthcare Inspectorate (IGJ). She represented the IGJ within the European Competent Authorities working group for Compliance and enforcement. Currently, she is the lead of the European Authorized Representative service, Person Responsible for Regulatory Compliance (PRRC), the contact person for European Competent Authorities, vice-chair of the European Association of Authorized Representatives (EAAR), and takes part in several European Commission working groups, addressing regulatory questions/issues related to the MDR. Additionally, she advises manufacturers and other Economic Operators, as well as healthcare institutes on regulatory compliance, strategies, market access, Notified Body challenges, and more. Areas of expertise include European medical device legislation, borderline issues, AI, classification of medical devices, Post Market Surveillance, and Competent Authority supervision.