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.
Profile →npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management). ## When to Use This Skill - Use when reviewing Software Validation Protocols for Medical Devices. - Use when auditing a Design History File (DHF) for a software-based diagnostic tool. - Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records. - Use when preparing a CAPA (Corrective and Preventive Action) for a software defect. ## How It Works 1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review. 2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304. 3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations. 4. **Correction Guidance**: Get actionable steps to resolve each findin
- Overview
- When to Use This Skill
- How It Works
- Examples
- Example 1: CAPA Root Cause Review
- Best Practices
- Limitations
What does the fda-medtech-compliance-auditor skill do?
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
How do I install it?
Run `npx skills add sickn33/agentic-awesome-skills --skill fda-medtech-compliance-auditor --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From sickn33/agentic-awesome-skills, a repository with 44,414 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.