What problem does it solve? Reviewing Post-Market Surveillance Plans and Periodic Safety Update Reports against EU MDR 2017/745 is time-consuming and error-prone, and missing a single Article 84 or Article 86 requirement can trigger a Notified Body non-conformity. This Skill performs a systematic, checklist-driven audit the way a Notified Body auditor would. ## Core Features & Use Cases - PMS Plan Audit: Reviews PMS Plans against Article 84 and MDCG 2025-10 across 12 sections covering data sources, vigilance timelines, signal detection, PMCF integration, and record keeping. - PSUR Audit: Reviews PSURs against Article 86 and MDCG 2022-21 across 13 sections including safety summaries, trend analysis, benefit-risk evaluation, and FSC status, with class-based frequency verification. - ISO 13485 Cross-Reference: Maps findings to QMS clauses 8.2.1-8.2.4 and 10.2 for feedback, complaints, regulatory reporting, internal audit, and corrective action. - Structured Audit Report: Generates a categorized findings report (CRITICAL/MAJOR/MINOR/INFO) with an overall compliance status and uploads it to the IMA knowledge base. - Use Case: Upload a Class IIb device's PSUR and receive a full gap analysis citing specific MDR articles and MDCG guidance sections, with prioritized corrective actions. ## Quick Start Audit the attached PMS Plan for our Class IIa device against EU MDR Article 84 and generate a compliance report.
