MDR Module 5: Investigation of Events

As an industry, we often do not adequately conduct and document a thorough investigation into the events leading to the Medical Device Report.

During Investigation of Events, the FDA shares expectations related to documented justification to support the conclusions made in the investigation. The FDA also recognizes the challenges faced by industry when the device is not returned for investigation. Participants accordingly can learn what constitutes adequate patient follow-up and good faith effort. 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

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

Level

Intermediate
 

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
     

Price

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