Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
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Oct 27, 2022 - Python
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iso-14971
Here are 7 public repositories matching this topic...
We help you commercialise your open source medical software.
python ai ml dicom segmentation radiotherapy medical-physics radiation-oncology iec-62304 pynetdicom radiation-physics radiation-therapy iso-14971 iso-13485 iec-62366
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Sep 9, 2023 - Python
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
risk-analysis blockchain cybersecurity risk-assessment mitm-attacks ns-3 intrusion-detection-system risk-management iso-27001 federated-learning iso-14971 iomt cybersecurity-tools iso-27005 iomt-security risk-awareness iso-11073 iec-80001-1
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Jun 7, 2026 - C++
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.
samd clinical-research iec-62304 iso-14971 intracranial-pressure craniosynostosis aurora-cranio fronto-orbital-advancement non-prescriptive posterior-vault-distraction specialist-support suture-biology skull-growth cranial-vault-remodeling aurora-neuro open-research-clinical-os
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Jun 30, 2026 - JavaScript
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.
fda healthcare starter-kit hipaa samd gdpr risk-management medical-device ai-agents iec-62304 iso-14971 iso-13485 digital-health healthtech regulatory-compliance software-as-a-medical-device claude-code medical-device-software
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Jul 6, 2026 - Python
FDA regulatory reviewer agents for Claude Code — 5 specialist personas for SaMD submission readiness, clinical safety, QMS compliance, cybersecurity, and human factors review
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May 3, 2026
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.
linux-kernel eeg ecg spo2 embedded-linux medical-device iec-62304 regulatory iso-14971 biosensor fmea zephyr-rtos medical-software
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Jul 3, 2026
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