Tuesday, 25 June 2019
8:30 am–5:00 pm CDT
The MDR transition date of May 26, 2020, is fast approaching and device manufacturers are laboring to update their technical documents and processes to meet the standards. If you are feeling the pressure to get your CERs compliant in time, you are not alone!
Join others from the local regulatory community as subject matter experts Keith Morel, PhD and Dr. Matthias Fink deliver concentrated CER-specific content supported with case studies, an interpretation from a Notified Body’s perspective and different approaches for transitioning to the MDR.
Featured presentations will include:
- Article 120 and the Soft Transition to the MDR
- Changing Clinical Data Requirements and Sufficient Clinical Evidence under the EU MDR
- Case Studies – Sufficient Clinical Evidence
This full-day workshop is brought to you by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking opportunities for professionals in the local regulatory community. Participants can claim six hours of educational credit and RAC holders may claim six RAC recertification credits.
Keith Morel, PhD, vice president, regulatory compliance, Qserve Group US
Dr. Matthias Fink, clinical reviewer, Clinical Centre of Excellence at TÜV SÜD