fda-medtech-compliance-auditor
fda-medtech-compliance-auditor是一款legal方向的AI技能，核心价值是Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820，可用于解决开发者在legal领域的实际问题，帮助用户提升效率、自动化重复任务或优化工作流。
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
mkdir -p ./skills/fda-medtech-compliance-auditor && curl -sfL https://raw.githubusercontent.com/sickn33/antigravity-awesome-skills/main/skills/fda-medtech-compliance-auditor/SKILL.md -o ./skills/fda-medtech-compliance-auditor/SKILL.mdRun in terminal / PowerShell. Requires curl (Unix) or PowerShell 5+ (Windows).
Skill Content
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
🎯 Best For
- Engineering teams doing code reviews
- Open source maintainers
- Claude users
- AI users
💡 Use Cases
- Reviewing pull requests for security vulnerabilities
- Checking code style consistency
- Using fda-medtech-compliance-auditor in daily workflow
- Automating repetitive legal tasks
📖 How to Use This Skill
- 1
Install the Skill
Copy the install command from the Terminal tab and run it. The SKILL.md file downloads to your local skills directory.
- 2
Load into Your AI Assistant
Open Claude and reference the skill. Paste the SKILL.md content or use the system prompt tab.
- 3
Apply fda-medtech-compliance-auditor to Your Work
Provide context for your task — paste source material, describe your audience, or share existing work to guide the AI.
- 4
Review and Refine
Edit the AI output for accuracy, tone, and completeness. Add human insight where the AI lacks context.
❓ Frequently Asked Questions
Does this skill check for OWASP Top 10?
Security-focused review skills often include OWASP checks. Check the skill content for specific vulnerability categories covered.
How do I install fda-medtech-compliance-auditor?
Copy the install command from the Terminal tab and run it. The skill downloads to ./skills/fda-medtech-compliance-auditor/SKILL.md, ready to use.
Can I customize this skill for my team?
Absolutely. Edit the SKILL.md file to add team-specific instructions, examples, or workflows.
⚠️ Common Mistakes to Avoid
Blindly accepting AI suggestions
Always verify AI-generated review comments. Some suggestions may not apply to your specific codebase conventions.
Not reading the full skill
Skills contain important context and edge cases beyond the quick start.