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MedWatch Reportability Triage

Describe the device, paste the event details (PHI stripped), select patient outcome and causality hypothesis, and describe reporter context. Get §803.50(a)(1)/(2) reportability factors with reporting-timeline analysis, a 3500A draft framework with PHI placeholders, and escalation questions for the MDR coordinator including cluster-pattern and CAPA implications.

✓ Errs toward escalation; never produces 'not reportable' conclusion✓ Cluster-pattern check flagged separately (§820.100 CAPA)✓ Reporter context (manufacturer / user facility / importer) distinguished

Results in ~30 seconds · Saves ~3 hours per event

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