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Medical Device Complaints, MDRs, and Reports

May 23, 2017 - May 24, 2017

AdvaMed 350Join AdvaMed on May 23 – 24 in Washington, D.C. for an in-depth workshop exploring the latest tips and tricks on how to understand, handle, and measure medical device complaints, MDRs, and reports. Speakers hail from organizations such as FDA, Deloitte, Novasyte, Medmarc, and more.

Topics will include:

  • Complaints: Definitional questions
  • Setting up a complaint system
  • Handling complaints & trending
  • Recalls and other field actions
  • Understanding MDRs
  • An introduction to Health Hazard Evaluation (HHE)
  • Reporting and products liability
  • Part 806 reports of removals and corrections
  • Current FDA inspection and enforcement trends
  • Measuring the effectiveness of your complaint system

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.


AdvaMed Offices
701 Pennsylvania Ave., N.W., Ste. 800
Washington, DC 20004 United States
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(202) 783-8700