MDR Module 1: FDA Expectations - Compliant Medical Device Reporting Systems

This module of the Medical Device Reporting Series provides an overview of medical device reporting requirements, definitions and applications. This session goes beyond CDRH Learn, as the Chief of the MDR Policy Branch answers frequently asked questions, and interacts with participants during the session.

Expert Faculty

Sharon Kapsch
Chief, MDR Policy Branch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health

(Expert faculty titles and companies may have changed since the time of recording.)



Learning Impact

Upon completion of this training, participants will:

  • Gain comprehensive knowledge of FDA expectations and guidelines
  • Learn industry standard definitions/applications
  • Gain insights and answers to audience-generated questions


$99 per module
$840 for entire series (Receive a 15% discount for purchasing all 10 modules)