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