medical-device-software

SaMD Starter Kit — build Software as a Medical Device with an AI agent team. IEC 62304 + ISO 14971 compliance scaffolding, 10 specialized agents, multi-agent workflows, and a complete regulatory Design History File. For Claude Code.

An operational AI governance framework for a high-risk clinical triage system. Unifies EU AI Act, GDPR, and MDR compliance into a single architecture. Self-directed MBA portfolio project.

Simulation only, not a medical device. A desktop insulin pump simulator in C++17 + Qt 6 demonstrating safety-critical engineering practice: strong-typed clinical quantities, a compiler-enforced delivery choke point, exhaustive state machines, and fail-safe defaults.

Synthetic CGM analytics system for glucose trend detection, risk classification, simulated alerts, validation testing, and Streamlit dashboard visualization.

Agent skills for EU medical device regulation that say where the rules stop. Statute-pinned, ablation-measured, source-verified.

Huma — independent third-party profile of a public API surface, by API Evangelist. Huma (Huma Therapeutics Limited) is a United Kingdom-headquartered digital health and remote patient monitoring company that provides a regulated, configurable platform for building and running healthcare and life-sciences applications.