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.