Texas Chapter: Clinical Considerations For the New EU Regulations

RAC Credits
Friday, 21 September 2018 (6:00 PM) - Friday, 21 September 2018 (8:00 PM) (Central Time (US & Canada))
2500 Bee Caves Rd Bldg B120
Austin, Texas, USA, 78746-5869

Friday, 21 September 2018
6:00-8:00 pm CDT
Emergo by UL Headquarters
2500 Bee Cave Road
Building One, Conference Room B120
Austin, TX 78746
+1 512 327 9997

Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the new EU MDR. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including:

  • Key differences between the new regulation and the directives it replaces
  • Data from clinical investigations vs. literature review
  • The concept of equivalence
  • The additional scrutiny in the pre and post-market phase
  • MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR
  • How to ensure a smooth transition to MDR certification

This event is coordinated by the RAPS Texas chapter and is intended to encourage knowledge sharing and community development. A light meal will be provided and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Anna Calleja, MHS, cCE, cardiologist, clinical reviewer, TÜV SÜD

Registration Information:
RAPS Members:  $25
Nonmembers:  $40