NeVibeCode · 3 items
Skills and MCP tagged “eu-mdr”
risk-management-specialist skill Implements ISO 14971:2019 risk management for medical devices across product lifecycles. It guides hazard analysis, 5x5 matrices, and risk control.
Claude Code
862installs
regulatory-affairs-head skill A Claude skill for MedTech regulatory work: prepares FDA 510(k), De Novo and PMA packages, plus CE technical documentation under EU MDR 2017/745.
Claude Code
790installs
mdr-745-specialist skill This skill supports EU MDR 2017/745 device classification, technical documentation, clinical evaluation, and post-market surveillance planning.
Claude Code
737installs
