Xavier Health
QA/RA Institute for Medical Device Professionals
 

MDR Series


Download Summary of MDR Series

Course Format:

  • Webinar

Expert Faculty:

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 MDR’s 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:

The June 2011 through April 2012 webinar series will include several topics that are already offered on CDRH Learn; at the same time, the webinar series will carry of message of “Beyond CDRH Learn,” which will include answering FAQ’s 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 will be encouraged to watch the videos on CDRH Learn prior to joining the webinars.

Three Categories are established for this series:

Basic. One webinar will be given on a basic overview (introduction) to the FDA regulations and expectations for Medical Device Reporting. Target Audience: anyone wanting to learn more about MDR’s, those new to the industry, and those new to a position that involves MDR’s. Also would be of interest to consultants.

Intermediate. Several webinars will 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. Also would be of interest to consultants.

Advanced. Several webinars will involve panels of FDA and industry to discuss the most challenging aspects of MDR’s. These panelists will 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.

This series will include a couple of topics that are already offered on CDRH Learn (www.fda.gov/Training/CDRHLearn/ucm162015.htm). CDRH Learn has amazing recorded videos for a few topics.

Our coverage of topics that are included on CDRH Learn will carry a message of “Beyond CDRH Learn”, which includes answering FAQ’s that we get from industry thought leaders, having industry join the session to share best practices, etc.

We will encourage participants to watch the videos on CDRH Learn prior to joining our webinar. 

Course Introduction:

The first and only comprehensive coverage of FDA expectations and industry solutions for Medical Device Reporting. The CDRH/Xavier Webinar Series is a monthly program which began in June 2011. It has been developed to offer you comprehensive coverage of FDA expectations and industry proven solutions on the topic of Medical Device Reporting. This educational series, developed by the FDA and Xavier University, will be the only A to Z blueprint for MDR’s 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

Tuition:

Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.

Industry: $3465.00
†Small Companies: $2725.00
†††Startup/Academic: $740.00

Who Should Attend:

Medical Device Professionals across all industry functions.

Logistics:

This webinar series is now available for immediate access.