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mizcausevic-dev / medical-adverse-event-incident-card

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Healthcare-specific profile of the AI Incident Card. Maps severity/type fields onto FDA MedWatch (21 CFR §803), EU MDR vigilance (Articles 87 to 89), IMDRF AE Terminology, and a CTCAE-aligned 5-grade clinical severity scale. Healthcare-readiness scaffolding, not certification.

fda ai-safety healthtech ai-governance eu-mdr kinetic-gain-protocol-suite incident-disclosure imdrf medwatch adverse-event-reporting
  • Updated May 29, 2026

mizcausevic-dev / pharmacovigilance-review-reporting-hub

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Operator surface for adverse-event queue, signal-detection clusters, regulator-reporting deadlines (FDA MedWatch 15-day / EU MDR vigilance / PMDA), and causality-assessment workflow. Browser-only, no telemetry. AGPL-3.0.

adverse-events signal-detection pv static-html medical-device drug-safety pharmacovigilance healthtech pmda eu-mdr operator-surface kinetic-gain audit-stream medwatch
  • Updated Aug 22, 2026
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