SAFE014 - Medical Device Reporting

The Food and Drug Administration (FDA) uses Medical Device Reporting (MDR) to receive information about adverse medical device events from manufacturers, importers and user facilities (including HME/DME suppliers), so that these events can be detected and corrected quickly. This course provides you with information you'll need to comply with MDR requirements.

Learning objectives:

1. Define “medical device”; 
2. Explain the reasoning behind Medical Device Reporting; 
3. Explain how medical devices are categorized; 
4. Explain how user facilities are required to report medical device adverse events to the FDA; 
5. Explain the difference between “mandatory”; and “voluntary”; MDR; 
6. Establish MDR written procedures, record keeping policies and files; 
7. Establish procedures for complying with FDA medical device recall actions.

To successfully complete this course, you must attain a minimum score of 80% on the final exam and complete the course training survey.

Continuing education: VGM Education is authorized by IACET to offer 0.1 CEUs for this program.