Medical Device Safety Reporting

This course explores the process by which US and European regulatory agencies ensure the safety of medical devices used in medical facilities and homes every day by following up on adverse events. Topics in this course include: Adverse Events, Premarket Reporting, Marketed Devices, and Reports. After completing this course, learners will be able to identify the regulatory requirements in the medical device clinical trial and postmarketing environments as well as recognize device safety monitoring and reporting efforts in the US and Europe.

After this course learners will be able to identify the regulatory requirements in the medical device clinical trial and postmarketing environments. recognize device safety monitoring and reporting efforts in the us and europe.