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.

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

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

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.

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

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.

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.

IEC 62304 compliance documents for upstream embedded OSS drivers (Zephyr RTOS, Linux kernel IIO). SOUP records, FMEA, SRS, SDS — ready to adapt for your medical device project.