All free tools
CAPA priority scorer
A 1–5 SOD product (max 125). Your SOP defines the real thresholds and when a correction is enough.
Severity of harm if uncorrected
3
Occurrence / how often it shows up
3
Detectability (1 = always caught, 5 = likely missed)
3
27
Priority 2 — CAPA or documented justification
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. CAPA priority scorer does not submit to FDA, Notified Bodies, or IRBs.
Related tools
FDA pathway picker
510(k), De Novo, PMA or 510(k)-exempt — a structured first pass from class, predicates and novelty.
SaMD IMDRF category
Map significance of the information × healthcare situation to IMDRF SaMD categories I–IV.
IEC 62304 software safety class
Walk harm scenarios to Class A, B or C for medical device software.