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medwatch

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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 87–89), 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

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