Series Description

What Is The Challenge?

As a medical device manufacturer, you are aware that this topic is critical to master, since as an involved company you must establish a decision tree for determining risk to patient safety and potential product recall.

You are no doubt familiar that the FDA often has issues with the decision trees (or trigger points) established by companies; it also has found that companies struggle to stay on top of the numerous complaints received.

As MDRs are generated from complaints from patients, doctors, and others who have experienced some type of malfunction with the medical device, you as the involved manufacturer are then expected to respond in a way that is commensurate with the risk.
 

Here’s The Solution

This webinar series includes several topics that are already offered on CDRH Learn; at the same time, the webinar series carries of message of “Beyond CDRH Learn,” which answers FAQs obtained from industry thought leaders and having industry experts join several of the sessions to share best practices.

As a registered participant in the webinar series, you are encouraged to watch the videos on CDRH Learn prior to viewing the webinars.
 

MDR Series' Three Categories

  • Basic: One webinar gives a basic overview (introduction) to the FDA regulations and expectations for Medical Device Reporting. Target audience: anyone wanting to learn more about MDRs; those new to the industry; those new to a position that involves MDRs; or consultants.
  • Intermediate: Several webinars tackle the various elements discussed in the basic overview by diving deeper into the “how to” aspects. Target audience: those working directly with medical device reports and their management, or consultants.
  • Advanced: Several webinars involve panels of FDA and industry to discuss the most challenging aspects of MDRs. These panelists address best practices and will give advice. Target audience: those working directly with medical device reports, their management, and senior management. Also would be of interest to consultants.
     

Expert Faculty

Patrick Caines
Director, Product Surveillance
GE Healthcare

Kathleen Cummings
Nurse Consultant, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA

Linda Hoffman
Consumer Safety Officer, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA

William Huff
Public Health Analyst, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA

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

Laurel Macomber
Product Expert
BSI

Steve Niedelman
Lead Quality System & Compliance Consultant
King & Spalding

Nancy Pressly
Health Scientist
Center for Devices and Radiological Health, FDA

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

Susan Rolih
Senior Vice President
Meridian Bioscience

Victoria Schmid
Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA

Deb Yoder
Nurse Consultant, 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.)
 

Course Introduction

The first and only comprehensive coverage of FDA expectations and industry solutions for medical device reporting. The CDRH/Xavier Medical Device Reporting Series was developed to offer you comprehensive coverage of FDA expectations and industry proven solutions on the topic of medical device reporting and will be the only A to Z blueprint for MDRs that you, as a medical device company, will be able to access.
 

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
     

Who Should Attend

Medical device professionals across all industry functions.
 

Course Certificates

Each participant will receive a Certificate of Completion after each module attended upon the return of a completed evaluation form. Each participant will receive 0.1 CEU credits per hour of training. Access to webinar/s and link to the CEU evaluation form will be provided upon purchase.

Professional certification for MDRs (1.0 CEU) will be given to those who complete all 10 courses and the final exam (which can be administered remotely).
 

Individual Modules

Price

Registrants may purchase all 10 modules at a 15% discount, or may purchase individual modules at $99 each using the links above.

$840 for entire series (includes a 15% discount for purchase of all 10 modules)

Government Official: $0.00 (must have valid .gov email account)