Detect FDA risk signals before they escalate. MAUDE, recalls, and competitor intelligence, harmonized in the cloud and built for MedTech quality teams.
Now a KeyPedia company
USA adverse-event data and risk signals, reimagined for speed.
Statistical anomaly detection and moving-average triggers for rising risk.
Daily MedTech recall alerts across product classes and device codes.
Corporate-level FDA signal intelligence and competitor benchmarking.
Cloud computation, Six Sigma black-belt tooling, game-theory principles, and quality-systems expertise, all in one workflow.
Control charts for CpK, threshold tolerance, and automated alerts turn raw adverse-event noise into decisions your quality team can act on.
On your cloud, direct from the FDA, cleaned and harmonized for critical workflows.
See where a device sits across adverse-event and product-problem axes at a glance.
Drill from product codes to manufacturers down to individual reports.
Game-theory principles and quality-systems expertise, not just a data dump.
e.g., Dexcom G6
Compare Abbott Libre 2 vs G6
Drill down into the metrics
Audit-ready, ready to use
Connect the dots. Automate FDA compliance in native cloud applications, custom-made for your team.
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