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6th Annual Medical Device Regulatory Affairs:
Securing Clearance & Maintaining Compliance Conference

 

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Hear about how regulatory affairs executives are working to secure approval for medical devices and maintain compliance with regulatory bodies in the US and abroad at the 6th Annual Medical Device Regulatory Affairs Conference.

CHECK OUT JUST A FEW OF THIS YEAR’S HIGHLIGHTED SESSIONS

  • Clarifying the Need for 510(K) Resubmissions for Modified Devices
    • Led by Marjorie Shulman, Director, Premarket Notification 510(k) Program, FDA
  • FDA Perspective- Expectations for Pre-Submissions and Other Requests for Feedback
    • Led by Erin Cutts, Biomedical Engineer, IDE Program, FDA
  • Case Study: Best Practices In Achieving UDI Implementation
    • Led by Thomas Denaro, Director of Corporate Regulatory Global Systems, & Montoya Love, Regulatory Systems Operations Manager of BD
  • Impact of Updates & Ensuring Compliance with ISO 13485:2016
    • Led by Greg Howard, Project Lead and Lead Auditor of DEKRA Certification
  • Industry Response & Preparation For EU Re-Registration Requirements For CE-Marked Devices
    • Led by Gert Bos, Director of the Board of RAPS

 

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