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fda-consultant-specialist

95 / 100 · Low risk

Fine to try.

By ArogyaReddy/alirezarezvani-claude-skills (GitHub) · other · 39 stars · scanned at commit dc799ac

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.

Works with any agent that supports SKILL.md skills.

What this skill can do

Other copies in this repository

ArogyaReddy/alirezarezvani-claude-skills has 1 more folder with a skill named fda-consultant-specialist. This page shows the lowest-scoring copy.

• .gemini/skills/fda-consultant-specialist 100/100 · Low risk

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'fda-consultant-specialist' ] || [ -L ~/.agents/skills/'fda-consultant-specialist' ]; then echo 'A skill folder named fda-consultant-specialist already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/ArogyaReddy/alirezarezvani-claude-skills' "$d" && git -C "$d" checkout --quiet 'dc799ac68cfdc454fc55edaf3f054651f645f738' -- 'ra-qm-team/fda-consultant-specialist' && mkdir -p ~/.agents/skills && cp -R "$d"/'ra-qm-team/fda-consultant-specialist' ~/.agents/skills/'fda-consultant-specialist' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'fda-consultant-specialist' ~/.claude/skills/'fda-consultant-specialist' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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