iec-62304

Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.

We help you commercialise your open source medical software.

Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

C++23 logging modules for medical device software: bounded core, explicit in-memory audit, and reviewable design evidence.

Deterministic, bit-perfect AI inference for safety-critical systems

SaMD Starter Kit — build Software as a Medical Device with an AI agent team. IEC 62304 + ISO 14971 compliance scaffolding, 12 specialized agents, multi-agent workflows, and a complete regulatory Design History File. For Claude Code.

C++ Integration Test Framework using Google Test and Delegates

Layered embedded firmware framework (4-Layer: APP/DCA/DDI/DRV) showcasing ISR minimization, RTOS synchronization, and vendor isolation patterns. Renesas RA + Azure RTOS ThreadX. Read-only portfolio excerpt with domain IP redacted.

Pipeline verification for certifiable-* ecosystem. Validates complete provenance chain from data through deployment with cryptographic binding verification. Hash-only and full replay modes.

MICROROBOTs Iterative simulation for Clinical Adoption (MICROROBOTICA). A Qt 6 + OpenUSD based IDE for microrobotics simulation. Loads MIME experiments, allows for live parameter edits over ZMQ, creates USD recordings of simulations, and produces an IEC-62304 audit trail for clinical grade adoption.

Spec-driven development MCP server for AI coding agents — 8 phases, bi-directional traceability, and 7 quality gates, 15 tools over Streamable HTTP (MIT)

Deterministic model packaging and cryptographic attestation for safety-critical ML deployment

End-to-end test harness proving bit-identity across platforms. Runs all 7 certifiable-* stages, generates golden references, and verifies deterministic execution. Proven identical: Linux/GCC ↔ macOS/Clang.

Agent skills for Claude, GitHub CoPilot and other AI agents

Regulatory-grade FHIR R4 API validation suite — IEC 62304 Class C, full IQ/OQ/PQ lifecycle, 80 automated test scenarios, HL7 Validator conformance layer, GitHub Actions CI

Automate requirements traceability: trace requirements to tests and code, fail CI on gaps, generate audit-ready traceability matrices.

Deterministic runtime monitoring for safety-critical ML. Hash-chained audit ledger, drift detection (TV/JSD/PSI), COE policy enforcement, and tamper-evident logging. 253 tests passing.

Deterministic, certifiable model quantization (FP32→Q16.16) with formal error bounds and cryptographic proof certificates. Pure C99. Zero malloc. DO-178C/IEC 62304/ISO 26262 ready.

Browser-based contouring workspace for radiation oncology — reference SaMD implementation using MedHarness for IEC 62304 DHF and CR workflow