Skip to content
#

medwatch

Star

Here are 2 public repositories matching this topic...

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

Star 0

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

mizcausevic-dev / pharmacovigilance-review-reporting-hub

Star 0

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 Jun 2, 2026
  • HTML

Improve this page

Add a description, image, and links to the medwatch topic page so that developers can more easily learn about it.

Curate this topic

Add this topic to your repo

To associate your repository with the medwatch topic, visit your repo's landing page and select "manage topics."

Learn more