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 17 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
J.D. Sharp — Biomedical engineer building Physical AI-driven manufacturing systems for medical device design, surgical robotics, and electromechanical systems. ISO 13485 design control through clinical translation.
computer-vision embedded-systems biomedical-engineering motion-control additive-manufacturing iso-13485 nvidia-omniverse surgical-robotics unc-chapel-hill retrieval-augmented-generation physical-ai medical-device-design design-for-manufacture
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May 13, 2026 - HTML
MATLAB simulation of a UR5e surgical robot performing a laparoscopic trajectory with tissue-adaptive PID force control and safety watchdog. Models soft tissue, organ wall, and cortical bone using spring-damper mechanics. Watchdog halts tool in 10ms. Verified per ISO 13485 and IEC 60601-1.
robotics matlab inverse-kinematics pid-control iso-13485 force-control medical-devices surgical-robotics
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May 20, 2026 - MATLAB
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
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
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Feb 8, 2026 - TypeScript
Automates medical device receiving inspection using Claude Code. Scans PO folders, cross-references COCs, packing slips, drawings, and receiving lists, then fills and exports a Quality Product Release Form (PRF) — designed for ISO 13485 / FDA 21 CFR Part 820 workflows..
python automation quality-management iso-13485 medical-devices receiving-inspection claude-code fda-21-cfr-820
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May 20, 2026
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
SalarSurgicals — premium surgical instruments manufacturer & exporter from Sialkot, Pakistan. ISO 13485, CE marked, FDA registered.
exporter manufacturer pakistan medical-supplies iso-13485 medical-devices surgical-instruments orthopedic-instruments sialkot ce-marked
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May 14, 2026
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
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
SalarSurgicals — premium surgical instruments manufacturer & exporter from Sialkot, Pakistan. ISO 13485, CE marked, FDA registered.
exporter manufacturer pakistan medical-supplies iso-13485 medical-devices surgical-instruments orthopedic-instruments sialkot ce-marked
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May 14, 2026
Cloud Assisted Records and Operations - a quality management software. Device agnostic web-app for local Apache- or IIS-server environments
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May 21, 2026 - PHP
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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