Post-Market Surveillance Module 3: Medical Device Reporting (MDR)

Medical Device Reporting (MDR) has become a weak spot for many companies as one of the top causes for FDA citations over the last few years. This 1.5 hour webinar deep-dives into the key components of a MDR report and how to meet FDA expectations. Sharon Kapsch, Chief of the MDR Policy Branch within FDA CDRH’s Office of Surveillance and Biometrics, provides insights on:

  • Common industry mistakes in MDR reports
  • FDA MDR investigations
  • Real case studies from the field
  • Key components of a MDR report

Sharon Kapsch is joined by expert Catherine Ricketts, a nurse analyst.  This course is a continuation of our MDR webinar series and it is recommended to complete these courses prior to attending this webinar.  A question and answer session follows the presentation.

 

Expert Faculty

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

Catherine Ricketts
Nurse Analyst
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 knowledge for the critical elements of a MDR report
  • Understand how to implement MDR best practices to meet FDA requirements
  • Possess tools to conduct a thorough MDR investigation


Certification

Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.
 

Price

$99 per module
$500 for entire series (Receive a 15% discount for purchasing all six modules)