Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
-
Updated
Oct 27, 2022 - Python
Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
We help you commercialise your open source medical software.
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
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.
Add a description, image, and links to the iso-14971 topic page so that developers can more easily learn about it.
To associate your repository with the iso-14971 topic, visit your repo's landing page and select "manage topics."