AI in your quality processes, without giving up rigour
Gordios automates the quality tasks that can be automated and assists your teams with the rest. Every conclusion is justified and sourced; important decisions stay human.
Best health innovation — Hacking Health Camp
In the health industries, AI is only worth something if it stays under control
A plausible answer does not stand up to an inspector. A conclusion must be traceable to its source, reproducible, and owned by a person. That is the frame we built Gordios in.
Automate what can be automated, assist with the rest
Not every quality process can be delegated the same way. Reviewing a document against requirements can be automated; investigating a deviation takes judgement. Gordios adapts to what each process allows you to delegate.
Your documents checked against your requirements, before they are even approved
Submit a procedure, an IFU or a technical file still in review: Gordios tests it requirement by requirement, against standards and your own procedures. Gaps surface before sign-off, not at the audit.
- Your requirements: built-in standards (MDR, ISO 13485, ISO 14971, IEC 62304, FDA QMSR) and tests derived from your procedures.
- Before approval: every new version is reviewed before it is approved.
- Sourced: every finding cites the requirement and the passage concerned.
A finding can be discussed, corrected or rejected; it never applies itself.
The compliance of your quality system, checked continuously
Rather than a snapshot before the audit, a standing check: Gordios re-runs your test sets at regular intervals and flags what changed. Every audit produces a scored report and a traceability matrix.
- Continuous: scheduled audits on your document library.
- Depth: hundreds of checkpoints, applied the same way every time.
- Actionable: findings ranked by criticality, PDF / Word report, requirement → test → conclusion matrix.
An uncertain result (confidence < 90%) goes to human review instead of being presented as settled.
Polton guides and challenges your deviation investigations
Polton takes the investigator from the facts to defensible CAPA, following the ELEMENTAIRE method of the Académie de la Qualité Efficace, deployed across many pharmaceutical sites. It asks for what is missing, challenges what does not hold, and never validates in your place.
- Guided, not free-form: each step asks for the evidence the next one needs, from 5W2H to CAPA.
- Named validation: every fact is locked by a person; the register is appended to the report.
- Beyond the investigation: Polton uses your deviation history to identify recurrences and feed your APQR.
Polton proposes and challenges; a named person always validates.
Built with
Every conclusion justified, every decision human
“Is your AI reliable?” deserves mechanisms rather than promises. Here are ours.
Every result cites its source
A finding names the clause it was judged against, so you can check the reasoning instead of trusting the verdict.
Confidence is scored independently
A separate agent scores each result. Below 90%, it is routed to human review rather than reported as fact.
Clause-level traceability
A matrix shows which requirements were covered by which tests, and what each one concluded.
A person validates, not the model
Facts are locked by named users. The validation register is printed in the report as an annex.
The prompts are version-controlled
What the model was instructed to do is recorded, numbered and recoverable — so you can produce the exact instructions a past decision was made under.
Built for regulated health industries
Same platform, different starting point.
Pharmaceutical & GxP
Polton for your deviations, from ICH Q9 to CAPA and APQR; review and audits of your documents against your own procedures. Built-in pharmaceutical standards are coming; today, your procedures are the reference.
Medical devices
Review and audits covering EU MDR, ISO 13485, ISO 14971, IEC 62304 and FDA QMSR, every finding traced to its requirement. Polton for your nonconformities and CAPA.
Consultants & notified bodies
Run the repetitive review in hours instead of days, and keep your judgement for the parts that need it. Checklists and reports are yours to hand over.
They trust us
Sarah Souheil Gebai
CEO TrembLess
My first impression of Gordios was shaped by the quality of the contact — not someone trying to sell me a service, but someone genuinely focused on guiding me through the specifications of my medical device. Before discovering Gordios, I had reached out to seven firms to estimate the cost of obtaining CE marking for my Class I device. The market price I was quoted ranged from €60,000 to €70,000. I assumed that was standard — until I found the solutions Gordios offered. Their pricing is highly competitive, and reaching out to them saved me valuable time. I highly recommend connecting with them early in your project.
Thomas Balverde
Regulatory Affairs Manager
I really appreciated the immediate relevance of Gordios' audit. Where I expected a simple document verification software, I discovered a true digital auditor capable of identifying discrepancies in my technical file in just a few minutes. Before, each revision of my QMS required several days of work, with a significant degree of uncertainty. I saved time, money, and above all, peace of mind. I cannot recommend Gordios highly enough before any audit!
Andrea Ballarin
CEO Hippocrate care
More than a solution, Gordios is a support and a partner in the development of your medical devices. We saved a lot of time and money by integrating Gordios right from the start of our development. A regulatory overview, but above all, a 360° view with experts, all in the blink of an eye. If you're a healthcare start-up, you should get in touch with the team!
Dr Céline Besnier
CEO SportSantéClic
Gordios has been a game-changer for me in setting-up our quality system. They provide an easy approach for a non-tech person like me and clearly reduced my time-to-market, while making my solution conform with all contract requirements.
In partnership with the Académie de la Qualité Efficace
Polton is built with the Académie, on its ELEMENTAIRE deviation handling method, deployed across many pharmaceutical sites.
Best health innovation
Gordios received the award at the Hacking Health Camp.
QARA and AI advisory
Beyond the platform, our team supports you on regulatory and quality matters, and on bringing AI into your processes.
Talk to usHave a question? Check out the FAQ
See Gordios on one of your documents, or one of your deviations
Thirty minutes, your documents, your findings. No preparation needed.