FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Install
npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialistnpx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a claude-code -gnpx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a codex -ggemini skills install https://github.com/alirezarezvani/claude-skills.git --path ra-qm-team/fda-consultant-specialistgh skill install alirezarezvani/claude-skills fda-consultant-specialistgit clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/alirezarezvani__claude-skills
mkdir -p ~/.claude/skills ~/.agents/skills
cp -R /tmp/alirezarezvani__claude-skills/ra-qm-team/fda-consultant-specialist ~/.claude/skills/fda-consultant-specialist # Claude Code
cp -R /tmp/alirezarezvani__claude-skills/ra-qm-team/fda-consultant-specialist ~/.agents/skills/fda-consultant-specialist # Codex, Cursor, Gemini CLI, Copilot, OpenCode