{"id":"be2e1074-9b96-4c3b-a891-e02f6e68ba9f","shortId":"vzP6e5","kind":"skill","title":"fda-medtech-compliance-auditor","tagline":"Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.","description":"# FDA MedTech Compliance Auditor\n\n## Overview\n\nThis 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).\n\n## When to Use This Skill\n\n- Use when reviewing Software Validation Protocols for Medical Devices.\n- Use when auditing a Design History File (DHF) for a software-based diagnostic tool.\n- Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records.\n- Use when preparing a CAPA (Corrective and Preventive Action) for a software defect.\n\n## How It Works\n\n1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review.\n2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.\n3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.\n4. **Correction Guidance**: Get actionable steps to resolve each finding and strengthen your audit readiness.\n\n## Examples\n\n### Example 1: CAPA Root Cause Review\n\n**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.\n\n**Finding:**\n\n```text\nFDA AUDIT FINDING\nSeverity: Major\nCitation: 21 CFR 820.100(a)(2) / IEC 62304 Section 5.1\n\nAnalysis:\n\"Developer error\" is a symptom, not a root cause. Retraining alone is\na known red flag for FDA inspectors and will not withstand scrutiny.\nThe true root cause lies in the software requirements engineering\nprocess itself — not an individual.\n\nRequired Actions:\n1. Perform a 5-Whys or Fishbone analysis targeting the requirements\n   gathering and review process.\n2. Update the SRS (Software Requirements Specification) and the\n   corresponding process SOP.\n3. Document an effectiveness check with a measurable criterion\n   (e.g., zero requirements-related defects in next 3 releases).\n4. Do not close the CAPA on retraining alone.\n```\n\n## Best Practices\n\n- ✅ **Do:** Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.\n- ✅ **Do:** Expect strict interpretations — the goal is to find weaknesses before a real inspector does.\n- ❌ **Don't:** Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.\n- ❌ **Don't:** Assume \"we tested it and it works\" satisfies IEC 62304 software verification requirements.\n\n## Limitations\n- Use this skill only when the task clearly matches the scope described above.\n- Do not treat the output as a substitute for environment-specific validation, testing, or expert review.\n- Stop and ask for clarification if required inputs, permissions, safety boundaries, or success criteria are 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