Skill UI

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.

An operational compliance tool for the EU AI Act (Regulation (EU) 2024/1689). It assists compliance teams with three critical decisions: classifying AI risk tiers (prohibited, high, limited, minimal), planning conformity assessment routes for high-risk systems (Module A vs. Module H), and tracking role-specific obligations for providers, deployers, and importers. Provides article-cited guidance for system intake and regulatory planning.