SAFE014 - Medical Device Reporting
This course provides you with information you'll need to comply with MDR requirements.
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.