fda-consultant-specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k
By alirezarezvani · 798 installs
npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist