Individual skill

fda-consultant-specialist

FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.

ra-qm-team/fda-consultant-specialist/SKILL.md

Source commit 25bf86b89c6c1e63f433a5b65e8cfcb6cf0b7ad3

What was checked

Matches the observed repository HEAD

Yes

Scanner rules are current

Yes

Repository scan complete

No

Skill scan complete

No

Observed behavior

Network or broad shell

Last checked

Nov 10, 2026

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