What problem does it solve? Medical device manufacturers must maintain compliant post-market surveillance and vigilance systems across multiple jurisdictions (EU MDR, FDA, NMPA, PMDA), each with different reporting timelines, PSUR requirements, and FSCA procedures that are difficult to track and operationalize. ## Core Features & Use Cases - PMS Plan & PSUR Generation: Builds a 9-part PMS Plan framework (data sources, metrics, CAPA triggers, responsibilities) and PSUR templates aligned to device class under EU MDR Articles 83-86. - Global Vigilance Timelines: Provides reporting deadline matrices and decision trees for serious incidents, FSCA/FSN, and trend reports across EU, FDA, China NMPA, Japan PMDA, Health Canada, and TGA. - Cybersecurity & AI Monitoring: Covers vulnerability management SLAs by CVSS score, coordinated vulnerability disclosure, and EU AI Act post-market monitoring for high-risk AI medical devices. - Use Case: A Class IIb device manufacturer entering the EU market uses this Skill to generate a complete PMS Plan, a PSUR template, and a vigilance reporting workflow with correct 10/15-day timelines and EUDAMED registration steps. ## Quick Start Ask the assistant to generate a PMS plan and vigilance reporting timeline for your Class IIb medical device sold in the EU and US markets.
