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- 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 employed to accurately predict which of the tiny minority of cases should be reported to the FDA
- Save time and resources by automating detection of adverse events
- Improve FDA compliance metrics