Principal Consultant-EU MDR /IVDR

NSF International

Michael Chellson has over 30 years of experience in the field of Medical Devices, as a laboratory scientist, an operational quality assurance leader, and as a Global Quality and Regulatory leader. He began his career working with QA, microbiological and sterility testing for processed food. However, career opportunities in small and large medical device manufacturers led to increasingly senior positions in QA/RA leadership and consulting.

Most recently Michael has been focused on assisting organizations with EU MDR compliance since publication of the first EC draft.

Roles of note in Michael’s career include Global Director RA with Sunrise Medical and VP RA/QA with ConMed Corporation. Michael also served with several USFDA workgroups, first as an industry partner in development of published FDA product safety guidance (SHBWG) and later as a member of initial USFDA “Case for Quality” initiatives.

Corporate Director, Regulatory Affairs

MED-EL

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs for MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria. MED-EL is active in over 123 markets worldwide with over 30 regional offices. As the leading global hearing implant company, MED-EL manufactures active implantable medical devices marketed globally.

Joining MED-EL in 2006, she currently leads the corporate regulatory affairs function responsible for all markets for product licensing, registrations/re-certifications, post-market vigilance activities, regulatory strategies for new product developments and related compliance activities internally and externally to new regulations and standards. She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities.

Prior to this Elizabeth worked in the telecommunications sector in regulatory compliance and data protection in Vodafone Ireland located in their head offices in Dublin. Her educational background is in social sciences, with her graduate and post graduate studies and thesis in Sociology completed at the University of the Witwatersrand, South Africa where she was active as a lecturer and social researcher.

Vice President CRHF Regulatory Affairs

Medtronic

As leader of the Medtronic CRHF Regulatory Affairs function, Rita is responsible for strategy creation and implementation, talent development, delivering approvals to support all therapy area portfolios and driving functional excellence.

Rita has held previous roles at Medtronic, including Sr. Director of Heart Failure & Tachy Quality, Supplier Quality Director, Product Development Core Team Leader and Commodity Manager/Technical Sourcing Specialist.

Rita has been with Medtronic 20 years and has 29+ years of product development, quality, regulatory and sourcing experience in the Medical Device industry. Her previous roles include positions with St. Jude Medical, DiaSorin, and the University of Minnesota Hospital and Clinics.