Skill UI

Provides FDA regulatory guidance for medical device manufacturers encompassing pathway strategy for 510(k)/PMA/De Novo submissions, QSR compliance, HIPAA assessments, and cybersecurity planning to support premarket filings.

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.

A suite of 12 production-ready compliance agents and tools designed specifically for HealthTech and MedTech organizations. These skills cover critical international regulations and standards, including ISO 13485, EU MDR, FDA 510(k)/PMA, ISO 27001, GDPR, and risk management (ISO 14971). Use them to automate compliance tasks, manage documentation, conduct audits, and ensure adherence to global medical device standards.