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FDA Medical Device Reporting

Course Details:

  • Category: Clinical
  • Duration: 30 minutes
  • Target Audience: All Employees

Course Overview: Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Training Includes:

  • Types of Monitoring from the FDA
  • FDA Inspections
  • Device Performance
  • Potential safety issues
  • Risk assessments
  • Reporting Requirements
  • Medwatch Forms