The ultimate complaint classification software

Automated classification and standardizing of post-market complaint data with greater than 80% accuracy.

Powerful features to boost productivity

Automatically classify complaint data and assign harmonized codes reducing manual efforts increasing accuracy and productivity.

Work efficiently

Automatically classify and assign medical device harmonized adverse event codes.

Your source of truth

Provides a single location for all complaint data with accurate FDA, MDR, and IMDRF code classifications.

Report generation

Automatically generate reports or outputs for submissions or internal tracking.


SmartComplaints™ improves efficiency and accuracy of raw complaint report classification and IMDRF code classification remediation.

Monitoring made easy

Provide an analytics dashboard for monitoring complaints trending.

Real-time trending

Perform real-time trending of risks approaching or exceeding acceptable thresholds.

Connect departments

Provide a platform or workstation for cross-departmental collaboration.
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