Skill UI

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

A rigorous simulation tool for auditing a medical device's Quality Management System (QMS) against ISO 13485 standards. It forces checks on six critical areas: Design History Files (DHF), CAPA effectiveness, Process Validation, Risk Management, Post-Market Surveillance, and Management Review. Essential for pre-audit, MDR, and FDA QSR alignment.