Agent skill · research science · sickn33
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.
Why this skill is useful
Provides specialized knowledge on FDA regulations and compliance standards for medical devices that the AI wouldn't reliably generate on its own.
What it needs
About 2k tokens when loaded. Last updated 2026-08-07. 44,571 stars on the source repository.
What this skill does
FDA MedTech Compliance Auditor Overview This skill assists a qualified medical-device quality/regulatory reviewer; it does not confer auditor certification or FDA approval. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (current QMSR; historical QSR requirements must be dated), 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 finding and strengthen your audit readiness. Examples Example 1: CAPA Root Cause Review Scenario: A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining. Finding: Best Practices ✅ Do: Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review. ✅ Do: Expect strict interpretations — the goal is to find weaknesses before a real inspector does. ❌ Don't: Forget to link every software defect to a clinical risk item in your ISO 14971 risk file. ❌ Don't: Assume "we tested it and it works" satisfies IEC 62304 software verification requirements. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills sickn33/fda-medtech-compliance-auditor