MedCon 2010 Regulatory Track AgendaRegulatory Track Agenda

Information will be updated as the agenda detail is finalized.

  • International Filing Requirements – managing different agencies
  • Combination Product Filings – tips for successful application
  • Regulatory Impact of Design and Process Changes – when to file 510k
  • MDR’s (AE’s, vigilance, follow-up, evaluating complaints)
  • Promotion of Device Prior to Approval
  • FDA’s International Initiatives
  • Joint Session with Clinical:  integrating regulatory and clinical plans

Strategic Committee Member

Chris Nelson, Marsh USAChris Nelson

Consultant, Marsh USA
Former FDA representative on GHTF

 

 

Please contact Marla Phillips if you would like to be considered for speaker or moderator opportunities.