All free tools
Intended-use claims highlighter
A word list, not a lawyer. Marketing pages and IFUs that say diagnose/treat/prevent usually move the regulatory object.
diagnosetreat
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. Intended-use claims highlighter does not submit to FDA, Notified Bodies, or IRBs.
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510(k), De Novo, PMA or 510(k)-exempt — a structured first pass from class, predicates and novelty.
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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.