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.

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, 10 specialized agents, multi-agent workflows, and a complete regulatory Design History File. For Claude Code.

AI-assisted development harness for IEC 62304 medical software teams — includes dhfkit, a standalone DHF traceability engine

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.

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.

Interactive ISO 13485 quality desk (synthetic plant): CAPA 8D, sticker≠cert, supplier SCARs, CSV binder.

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

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

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