MDR Module 2: eMDR Implementation

During eMDR Implementation, Reilly goes beyond CDRH Learn to share more insight on the “how to” aspects of filing electronic Medical Device Reports. Understand not only the expectations but insight on how to fulfill the expectation.

In addition, Rolih shares a case study of how Meridian Bioscience struggled to overcome the challenges of transitioning to the new format of filing MDR’s. She shares the secrets of what they learned so you can also apply these insights to your company. A question and answer session takes place at the close of the presentation.
 

Expert Faculty

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

Susan Rolih
Senior Vice President, Regulatory Affairs and Quality Assurance
Meridian Bioscience, Inc.

(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)