MDR Module 3: MDR Procedures and Event Files

MDR Procedures provides a forum for the FDA to share best practices for developing, maintaining, and implementing MDR procedures. A question and answer session takes place at the close of the main presentation.

Expert Faculty

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

Laurel Macomber
Product Expert

(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)