fda-medtech-compliance-auditor

# 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 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. **Findi...