Come join colleagues from your local regulatory community for an evening of networking and to hear two presentations on global regulations. This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.
Presentation One: Updates on EU RegulationsThis session will focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation and In Vitro Diagnostics Regulation. Topics covered will include:
Part 2: Updates on the US 510(k) ProcessThis session will focus on recent experience with the new 510(k) substantial equivalence guidance and flowchart as well a practical discussion of what is going on today in 510(k) reviews. Topics covered will include:
Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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