# Gordios

> SaaS platform that automates document verification for medical device regulatory files.

Gordios automates the verification of regulatory documentation for medical device manufacturers. It is built around two pillars:

**Turnkey QMS audit.** Gordios runs a full audit of a Quality Management System against a chosen regulatory framework — ISO 13485, ISO 14971, EU MDR 2017/745, IVDR, or FDA QMSR — and identifies gaps and non-conformities in minutes instead of days.

**Custom automated test sets.** Users build their own verification checklists directly in the platform, or let Gordios analyze their SOPs and suggest relevant test sets automatically. These tests can then be run by authorized team members — R&D, manufacturing, and others — to automate document review across Technical Files, Instructions for Use, and more. Regulatory Affairs no longer needs to be in the loop for every check.

Every finding is justified with a precise reference to the source document, with full explainability of the reasoning and traceability. The platform is hosted in Europe on an ANSSI-certified cloud and supports multiple AI models.

## Key Features

- **QMS Audits**: Run a full Quality Management System audit against ISO 13485, ISO 14971, IEC 62304, IEC 62366, EU MDR, IVDR, or FDA QMSR. Identifies gaps and non-conformities with precise document references.
- **Custom Test Sets**: Build custom verification checklists or let the platform analyze SOPs and suggest test sets automatically. Delegate execution to R&D, manufacturing, or other authorized team members.

## Pages

- [Homepage](https://www.gordios.app/en/): Overview of the Gordios platform and its capabilities.
- [Pricing](https://www.gordios.app/en/pricing): Plans and pricing for Gordios.
- [Publications](https://www.gordios.app/en/publications): Insights on medical device regulation, AI compliance, and QA best practices.
- [About Us](https://www.gordios.app/en/about-us): Mission, values, and team behind Gordios.
- [How Gordios is built](https://www.gordios.app/en/trust-ai): Traceability, explainability, and security design of the Gordios platform. EU hosting, source citation, confidence scoring, manual review thresholds.
- [Security and hosting](https://www.gordios.app/en/security): Data hosting, jurisdiction, and security processes. EU hosting, SecNumCloud partners, ISO 27001-aligned processes, pentest reports available under NDA.
- [Contact Us](https://www.gordios.app/en/contact-us): Get in touch or request a demo.
- [Partners Directory](https://www.gordios.app/en/partners-map): Find QARA, design, and development experts.
- [ISO 13485 Audit](https://www.gordios.app/en/check/13485): Automated ISO 13485 quality management system audit.
- [ISO 14971 Audit](https://www.gordios.app/en/check/14971): Automated ISO 14971 risk management audit.
- [IFU Compliance Check](https://www.gordios.app/en/check/ifu): Automated check of instructions for use — mandatory regulatory information and risk-to-warning traceability.
- [EU MDR Audit](https://www.gordios.app/en/check/mdr): Automated EU MDR 2017/745 technical documentation audit.
- [FDA QMSR Audit](https://www.gordios.app/en/check/qmsr): Automated FDA QMSR (21 CFR 820) quality management system audit.

## Regulatory Standards Covered

- EU MDR 2017/745 (Medical Device Regulation)
- ISO 13485 (Quality Management Systems)
- ISO 14971 (Risk Management)
- IEC 62304 (Software Lifecycle)
- IEC 62366 (Usability Engineering)

## Company

- Website: https://www.gordios.app
- Contact: contact@gordios.app
- LinkedIn: https://www.linkedin.com/company/gordiosapp

## Languages

Available in English and French.