Skill UI

Guides teams through EU MDR 2017/745 requirements for device classification, technical documentation, clinical evaluation and post-market surveillance, including Annex workflows, EUDAMED/UDI integration, and Notified Body interactions.

Guides HealthTech and MedTech teams through FDA 510(k)/De Novo/PMA and EU MDR CE marking, drafting strategy documents, agency responses, and multi-market plans for device submissions and compliance.

Suite of 12 production-ready HealthTech/MedTech regulatory and quality management skills covering ISO 13485, MDR 2017/745, FDA 510(k)/PMA, ISO 27001, GDPR/DSGVO, risk management, CAPA, documentation, and audits, plus stdlib Python helpers for compliance workflows.