FDA Manufacturer and User Facility Device Experience (MAUDE) Screener
Screens medical device adverse event reports against FDA MAUDE database reporting requirements.
Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.
How it works
Standard: FDA Medical Device Reporting (MDR) 21 CFR Part 803
Formula: Verify event type (Injury, Malfunction, Death) and mandatory reporting timeline compliance
Checks: Valid MDR event classification
Calculated locally in browser memory; nothing leaves your browser.
Deterministic local-first client-side execution. Provided as-is without warranty.