Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.
-
Updated
Oct 27, 2022 - Python
#
iso-13485
Here are 8 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
-
Updated
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
-
Updated
Sep 12, 2022 - Go
Compliance-Grade AI Localization Engine for Medical Devices. Features a "Safety Sandwich" architecture combining deterministic glossary enforcement, Hybrid GenAI translation (GPT-4o), and pixel-perfect UI constraint validation to prevent text overflow on patient monitors.
react i18n python docker typescript ci-cd healthcare openai xliff compliance medtech audit-trail mdr iso-13485 rag pydantic fastapi llm langchain genai
-
Updated
Feb 8, 2026 - TypeScript
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
-
Updated
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
-
Updated
Dec 23, 2025
Sistema de Documentação Regulatória para Dispositivos Médicos SaMD - Oncologia Hematológica | ANVISA/FDA/IMDRF Compliant | ISO 13485, IEC 62304, ISO 14971
-
Updated
Oct 23, 2025 - Python
Cloud Assisted Records and Operations - a quality management software. Device agnostic web-app for local Apache- or IIS-server environments
-
Updated
Feb 17, 2026 - PHP
Improve this page
Add a description, image, and links to the iso-13485 topic page so that developers can more easily learn about it.
Add this topic to your repo
To associate your repository with the iso-13485 topic, visit your repo's landing page and select "manage topics."