MDR Module 6: CFR 803 Definitions

CFR 803 Definitions provides two presentations, which will both prove to be valuable ongoing resources.

  1. The CFR 803 Definitions presentation offers a tool to industry to use to navigate the complicated and often misinterpreted definitions coming out of CFR 803. Understanding these definitions and the expectations of use are critical to the implementation of a compliant MDR system.  
  2. The MDR Event and Evaluation Codes presentation is loaded with case studies to help you understand how to apply FDA expectations.

A question and answer session takes place at the close of the main presentation.

Expert Faculty

Eugene Reilly
Public Health Analyst, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA

(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)