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MedTech Summit
16 - 20 June 2025
MOA BerlinBerlin, Germany

Elizabeth Gfoeller
Corporate Director, Regulatory Affairs at MED-EL
Advisor

Profile

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 123 markets have restored hearing to more than 200,000 individuals worldwide.

Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function responsible for over 123 markets globally 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.

Agenda Sessions

  • EU MDR: Timelines, Transitions and Tribulations

    08:40
  • Chairperson’s Opening Remarks: Software and AI for Medical Devices & IVDs

    08:30
  • Chairperson’s Afternoon Remarks: Software and AI for Medical Devices & IVDs

    14:10
  • Best Practices in Enterprise Evidence Management

    14:15