MDR Module 9: Managing Global Expectations for Medical Device Reporting Panel Session

During Managing Global Expectations for Medical Device Reporting, the panel discusses the expectations of the FDA versus other Global Regulators related to the topic of Medical Device Reporting. The Industry Experts share how they manage the different systems globally and remain compliant with so many different expectations and regulations. The group then addresses questions from participants.

Expert Faculty

Patrick Caines
Director, Product Surveillance
GE Healthcare

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

Laurel Macomber
Product Expert

Steve Niedelman
Lead Quality System & Compliance Consultant
King & Spalding

(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)