Skill UI

A comprehensive guide for Corrective and Preventive Action (CAPA) management within Quality Management Systems (QMS), specifically tailored for medical devices. It covers the entire investigation lifecycle, including root cause analysis (RCA) using methodologies like 5-Why and Fishbone diagrams, developing robust corrective actions, and verifying effectiveness to ensure continuous compliance and quality improvement.

This comprehensive guide provides expertise in conducting ISO 13485 internal audits for medical device Quality Management Systems (QMS). It covers the full audit lifecycle, including risk-based planning, systematic evidence collection, classifying nonconformities (Major/Minor), and managing CAPA verification to ensure regulatory compliance and continuous improvement.

This specialized AI acts as an auditor for Medical Devices (SaMD) compliance. It reviews critical documentation like Design History Files (DHF) and technical files against major global regulations, including 21 CFR Part 820, IEC 62304, and ISO 13485. It identifies compliance gaps, cites specific regulations, and provides actionable remediation steps to prepare for regulatory audits.

This skill assesses Bluetooth Low Energy (BLE) device security by scanning nearby devices, enumerating GATT services, and analyzing characteristics. It detects critical vulnerabilities such as unencrypted sensitive data exposure, weak pairing configurations, and known vulnerable device fingerprints, making it essential for IoT and medical device security auditing.

This tool performs a rigorous, simulated Quality Management System (QMS) audit based on ISO 13485 standards for medical devices. It forces interrogation on critical areas, including Design History Files (DHF), CAPA effectiveness, process validation, risk management (ISO 14971), and post-market surveillance (MDR/FDA QSR). Use it before major audits, commercial launches, or regulatory submissions to identify compliance gaps.