iso-13485

Our regulatory documentation manager. Streamlines 62304, 14971, and 510(k) documentation for software projects.

We help you commercialise your open source medical software.

Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

C++23 logging modules for medical device software: bounded core, explicit in-memory audit, and reviewable design evidence.

Top Medical Device Quality Management (Opensource) 🌟 Star if you like it! 🌟

SaMD Starter Kit — build Software as a Medical Device with an AI agent team. IEC 62304 + ISO 14971 compliance scaffolding, 12 specialized agents, multi-agent workflows, and a complete regulatory Design History File. For Claude Code.

CERN's quality assurance plan (QAP) to solve the document naming convention problem.

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

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.

YAML device spec to CE-MDR Annex II/III technical file skeleton in one command. Pure-Python CLI.

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.

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.

EMET is an MCP memory server built for ISO 9001 7.5.3 / ISO 13485 4.2.5 document control: shared memory for AI agents and bot teams. Nothing is deleted; records are superseded, retired and retained. Controlled templates, verified writes, a word-for-word transcript tier, a GEM socket for add-on modules, stdio and remote HTTP with OAuth, on MongoDB.

FDA regulatory reviewer agents for Claude Code — 5 specialist personas for SaMD submission readiness, clinical safety, QMS compliance, cybersecurity, and human factors review

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.

Lean, git-controlled ISO 13485 QMS template (Obsidian + Markdown). Scaffold + tooling, not a compliant QMS — see DISCLAIMER.

AI-assisted CAPA and root cause analysis for medical device quality teams. ISO 13485-aligned.

SalarSurgicals — premium surgical instruments manufacturer & exporter from Sialkot, Pakistan. ISO 13485, CE marked, FDA registered.

Design control and risk management documents worked against ISO 13485, ISO 14971 and EU MDR — self-directed exercise on an independent device design

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