Adverse Event Reporting

Adverse Event Reporting Solutions


  • Medical Device manufacturers need to report adverse events to the FDA in a timely manner
  • Today such reports are filed after manual inspection of each patient case where a device was used
  • Can be tedious and error prone – failure to comply could lead to financial penalties or even criminal sentences


  • The Adverse Events reporting solution applies AI to automatically detect adverse event cases.
  • Advanced ML techniques are employed to accurately predict which of the tiny minority of cases should be reported to the FDA


  • Save time and resources by automating the detection of adverse events
  • Improve FDA compliance metrics