Skill UI

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

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.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

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.