RAPS Twin Cities Chapter: An Update on Global Regulations

When:  May 11, 2017 from 17:30 to 20:30 (ET)

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 Regulations
This 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:

  • What are the critical changes within the new regulations?
  • What are the timelines for compliance?
  • What will be the impact on interactions with Notified Bodies?
  • What are the key steps to achieving compliance?

Part 2: Updates on the US 510(k) Process
This 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:

  • What factors initiate wanting a pre-IDE meeting?
  • How can 501(k) criteria be strategically presented?
  • What will it take to be successful in getting clearance today?
  • What factors will affect the overall FDA review?
    • Working with FDA review teams today
    • Guidance documents
    • Specialists
    • Dynamics of team review
    • Outside groups (industry and medical)
    • Scientific minutiae vs what’s truly important

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.