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-13485
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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
YAML device spec to CE-MDR Annex II/III technical file skeleton in one command. Pure-Python CLI.
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May 19, 2026 - Python
Sistema de Documentação Regulatória para Dispositivos Médicos SaMD - Oncologia Hematológica | ANVISA/FDA/IMDRF Compliant | ISO 13485, IEC 62304, ISO 14971
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Oct 23, 2025 - Python
A multi-agent system for rapid regulatory document review in medical devices. Uses Google ADK to fan out specialist agents (requirements, risk, test, guidelines), pipeline them through a summarizer, and loop in humans for low-confidence findings. Includes built-in tools (Google Search) and custom FunctionTools
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Nov 25, 2025 - Python
AIAG-VDA 2019 pFMEA generator suite — 3 medical device scenarios (CNC machining, injection molding, sterile packaging) | Python + openpyxl | 21 CFR 820 | ISO 13485 | ISO 11607
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May 17, 2026 - Python
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