Skill UI

A comprehensive guide for implementing ISO 14971:2019 risk management across the entire medical device lifecycle. Covers planning, hazard identification, risk analysis (FMEA, FTA), risk evaluation, risk control, and post-market surveillance. Essential for achieving regulatory compliance in medical device development.

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.