iso-14971

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.

Claude Skill: ISO 14971:2019 medical device risk management — risk analysis, evaluation, control, FMEA tooling, post-production surveillance

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.

AURORA-CRANIO Ω — Open research-clinical operating system for craniosynostosis biology, skull-growth mechanics, neurodevelopment, surgical topology, biomarker discovery, and outcome learning. 9 sections, 20+ modules, non-prescriptive safety contract.

Fails the build when a requirement has no code, no passing test, or a risk has no verified control. Traceability for medical device software, in the repo.

RAXHA — a Human State Intelligence System. Detects meaningful changes in a person's physiological, behavioral and contextual state and helps the right people respond in time. It does not diagnose or treat. Full traceability: doctrine → architecture → hazards → requirements → verification → evidence.

A Standards-Aligned IoMT Federated Learning and Blockchain Framework for MITM Mitigation and Risk Quantification using NS-3. Insights to be presented by R. M. Rajab at The 2nd IEEE 2026 International Conference on Cybersecurity and AI-Based Systems (Cyber-AI 2026) hosted on 22-25 Sept. 2026 at the Romanian-American University in Bucharest, Romania

FDA regulatory reviewer agents for Claude Code — 5 specialist personas for SaMD submission readiness, clinical safety, QMS compliance, cybersecurity, and human factors review

Design History File traceability matrix for SaMD: requirements → design → verification → validation → ISO 14971 risk controls, ingesting ML validation evidence from ml-samd-validator with three-band link confidence. FastAPI + React.

FDA GMLP + PCCP validation evidence for ML-based Software as a Medical Device: drift detection, subgroup fairness, PCCP change evaluation with three-band confidence routing. FastAPI + React.

Compliance-as-code V&V demo: requirements and ISO 14971 risk controls traced to BDD and TDD tests, with a CI-generated traceability matrix, verification report and quality gate. Synthetic module, not a medical device.

Design control and risk management documents worked against ISO 13485, ISO 14971 and EU MDR — self-directed exercise on an independent device design

Mapping Clinical AI failure mode analysis to regulatory and risk management frameworks - ISO 14971, NIST AI RMF, EU AI Act, FDA SaMD guidance. Built from public standards by a physician working in clinical AI safety.

IEC 62304-oriented reference documents for embedded OSS drivers: SOUP, FMEA, SRS and SDS examples

Traceability and reliability analyser for a medical device design history file: requirement to verification coverage, risk control checks, exact confidence intervals and Weibull fitting