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
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
CERN's quality assurance plan (QAP) to solve the document naming convention problem.
go golang engineering mechanical-engineering quality-assurance cern qap cae qms plm iso-13485 iso9001 iso-9001 product-lifecycle-management design-history quality-assurance-plan iso13485 document-naming quality-management-system
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Sep 12, 2022 - Go
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
Comprehensive Mastery Portfolio for Surgical Robotics & Haptics: A 4-year foundation in High-Performance C++ (Real-Time Systems) and Python (Data Science) for patient-specific medical simulation.
python real-time cpp embedded-systems haptics biomedical-engineering iec-62304 iso-13485 cpp23 medical-software patient-specific surgical-robotics
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Dec 23, 2025
Cloud Assisted Records and Operations - a quality management software. Device agnostic web-app for local Apache- or IIS-server environments
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Jan 7, 2026 - PHP
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