ALL111 - Medical Device Reporting (1.0 HR)

Purpose: This course is designed to provide employees of user facilities with pertinent information regarding the reporting requirements for medical device malfunctions. Objectives: 1. Define “medical device”; 2. Discuss the rationale for medical device reporting requirements; 3. Explain how user facilities are required to report medical device adverse events to the FDA; 4. Explain the difference between mandatory and voluntary MDR; 5. Discuss required recordkeeping; 6. Describe procedures for complying with FDA medical device recall actions.