fda-consultant-specialist

Quality score: 70/100 · Category: Security · Sub-category: compliance

ai:claude

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.

What this skill does

fda-consultant-specialist is a production-ready Claude Code skill (quality score 70/100) in the compliance sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/fda-consultant-specialist-alirezarezvani-claude-skills/ and loads when your prompt matches the skill's trigger.

When to invoke it: Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Who uses this skill

The fda-consultant-specialist skill is built for security engineers, penetration testers, DevSecOps practitioners, and development teams hardening codebases and infrastructure. It is part of the open ClaudSkills registry, a community-curated catalog of 15,000+ capabilities you can install for Claude Code — the Claude CLI agent.

How to install

Free

Manual install (2 steps)

mkdir -p ~/.claude/skills/fda-consultant-specialist-alirezarezvani-claude-skills
curl -L https://claudskills.com/skills/fda-consultant-specialist-alirezarezvani-claude-skills/SKILL.md \
  -o ~/.claude/skills/fda-consultant-specialist-alirezarezvani-claude-skills/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/fda-consultant-specialist-alirezarezvani-claude-skills/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/fda-consultant-specialist-alirezarezvani-claude-skills/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\fda-consultant-specialist-alirezarezvani-claude-skills\SKILL.md on Windows. See the full install guide for step-by-step instructions.

Pro

One-click install via the desktop app

The ClaudSkills desktop app installs any skill directly into ~/.claude/skills/ with one click — no terminal required. Pro starts at $9/mo or $149 lifetime.

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Part of ClaudSkills — the open registry for Claude Code skills. · What's New · Install guide · About · llms.txt

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