fda-medtech-compliance-auditor
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
Content Preview
--- name: fda-medtech-compliance-auditor description: "Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation." risk: unknown source: community --- # FDA MedTech Compliance Auditor ## Overview This skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quali
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/fda-medtech-compliance-auditor.md \
https://raw.githubusercontent.com/sickn33/antigravity-awesome-skills/main/skills/fda-medtech-compliance-auditor/SKILL.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/sickn33/antigravity-awesome-skillsThen reference at skills/fda-medtech-compliance-auditor/SKILL.md
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