Atlanta Chapter: Brexit and EU MDR – Are you Ready?

When:  Nov 21, 2019 from 08:30 to 19:00 (ET)

Prior to 8 November:
Member: $109
Nonmember: $129

On or After 8 November:
Member: $129
Nonmember: $149

The UK is due to leave the European Union (EU) on 31 October 2019. How will this impact your organization’s ability to import, export or market medical devices in the UK? 

The EU Medical Devices Regulation (MDR) will be fully implemented on 26 May 2020. Is your company ready for the more stringent requirements device manufacturers will need to meet? With less than eight months to go before implementation, manufacturers are running out of time to develop and adjust action plans to meet the new requirements.

Come join your peers from our local regulatory community for this full-day workshop that will provide a Brexit update and interactive presentations on EU MDR. Attendees will hear from subject-matter experts representing Qserve and R&Q, two of the top EU MDR consulting firms, as well as perspectives from well-known notified bodies, DEKRA and TÜV SÜD. Learn strategies to help you navigate the new regulation’s higher level of scrutiny and discuss EU MDR hot topics including:

  • Economic operators
  • Labeling/UDI/implant cards/Eudamed
  • Hazardous materials 
  • PMS/PMCF
  • Clinical data and evaluation

View the program agenda here.

The workshop will take place 8:30–5:00 pm, and since there is so much to cover on this topic, we’ve extended the program to also include a two-hour Q&A session, where you can ask specific questions of our expert panel. Our goal is to provide more value for our attendees, and we encourage you to stay for this portion of the program.

This event is intended for mid-level regulatory professionals who are responsible for applying the EU MDR requirements to their organizations’ products. Knowledge of the current Medical Devices Directive is not required but may be helpful. Basic knowledge of EU MDR requirements also would be beneficial but not required.

This workshop, hosted by our sponsor Avanos Medical, is brought to you by the RAPS Atlanta Chapter to facilitate knowledge sharing and networking among the Atlanta-area regulatory community. Continental breakfast, lunch and snacks during breaks will be available for all attendees, and RAC holders may claim six RAC recertification credits.

Featured speakers:
Matthias Fink, MD
, clinical reviewer, Clinical Centre of Excellence, TÜV SÜD
Claire McKenna, MBA, senior project manager, DEKRA Certification Inc.
Keith Morel, PhD, vice president, regulatory compliance, Qserve Group US Inc.
Ibim Tariah, PhD, vice president, EU MDR and IVDR consulting services, Regulatory and Quality Consulting LLC

Location

5405 Windward Pkwy
Alpharetta, GA 30004-4667