fda-consultant-specialist
by alirezarezvani (GitHub) in alirezarezvani/claude-skills
What it does
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
Quoted from the skill's SKILL.md under its MIT license.
Install
git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git /tmp/claude-skills mkdir -p ~/.claude/skills/ cp -r /tmp/claude-skills/ra-qm-team/skills/fda-consultant-specialist ~/.claude/skills/fda-consultant-specialist
The command copies the skill from the author's repo. SkillTrove does not host it.
Files
- SKILL.md
- references/device_cybersecurity_guidance.md
- references/fda_capa_requirements.md
- references/fda_submission_guide.md
- references/hipaa_compliance_framework.md
- references/qsr_compliance_requirements.md
- scripts/fda_submission_tracker.py
- scripts/hipaa_risk_assessment.py
- scripts/qsr_compliance_checker.py
Source: https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist. Checked 2026-10-13.
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