medical-device
Design-control checks for software teams — traceability, verification, SOUP and releases, as CI gates.
🔌 Exposes FDA AI/ML SaMD compliance over MCP — 510(k), De Novo, PMA, PCCP, GMLP. MIT
🔌 Exposes EU MDR (Reg 2017/745) + IVDR + AI/ML SaMD classification over MCP — MIT
