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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.

Objectives include:

  • Tyes of Monitoring from the FDA

  • FDA Inspections

  • Device Performance

  • Potential safety issues

  • Risk assessments

  • Reporting Requirements

  • Medwatch Forms