The quality system copilot for regulated health industries
Gordios puts AI on the quality work that eats your week - reviewing documents, investigating deviations, keeping the trail - so your team spends its time deciding, not compiling.
Built by QA experts for the QA teams of medical device and pharmaceutical manufacturers.
Best Healthcare InnovationAwarded by the Hacking Health Camp
Your team doesn't lack rigour — it lacks hours
Most of a quality team's week is mechanical: reading documents against requirements, hunting for the right version, writing up an investigation that follows the same steps as the last one. Expertise gets spent on the parts that don't need it.
And when the hours run out, things slip: a cross-reference nobody checked, an investigation that will not hold up under questioning, a document that went out without a second read.
Gordios takes the mechanical half — the reading, the structuring, the trail — so your team's judgement goes where it actually counts.
+10 years' experience
in medical devices
Every deviation, investigated the same way
A guided investigation takes an operator from the facts to a defensible CAPA in seven steps — the same seven steps, whoever runs it and however busy the week is.
The assistant asks for what is missing and challenges what does not follow. It does not sign anything off: each fact is locked by a named person, and the report carries that validation register as an annex.
- Guided, not free-form: the operator is asked for the evidence the next step needs.
- Named validation: every fact is locked by a person, never by the AI.
- Reviewable later: the report prints who validated what, and when.
The seven steps
- 1What happened
- 2Criticality (ICH Q9)
- 3Impact
- 4Primary cause
- 5Root cause
- 6Corrective & preventive actions
- 7Conclusion
Automated document checks
Checked clause by clause, in a couple of hours
Gordios reads your documentation and tests it against EU MDR, ISO 13485, ISO 14971, IEC 62304 and FDA QMSR — hundreds of checks in the time a manual review takes to schedule.
Every finding cites the requirement it came from, so a result can be argued with rather than taken on faith.
- Time: an audit in a few hours, against several days by hand.
- Depth: several hundred analysis points, checked the same way every time.
- Coverage: EU MDR, ISO 13485, ISO 14971, IEC 62304, FDA QMSR.
Your procedures, tested too
A standard is the floor, not the job. Upload one of your SOPs and Gordios derives conformity tests from it, so the platform enforces how your company actually works.
That is also how Gordios serves quality systems it ships no corpus for: your procedures are the reference.
- From your SOP: upload a procedure, get tests you can review and edit.
- Your wording: tests are grouped into sets and reused across audits.
- No corpus required: works for pharmaceutical quality systems today.
Clear, traceable, and actionable reports
Each audit generates a detailed report with figures, including an overall compliance rate, scores per section, discrepancies classified by criticality, etc. There is complete traceability, with each analysis linked to the corresponding standard or regulation.
This gives you a clear, documented, and immediately actionable overview to prepare your audits and demonstrate your compliance efforts.
- Detailed reports: scores, corrective actions, and gaps ranked by criticality.
- Full traceability: each analysis point linked to the corresponding rule.
- Operational clarity: a documented and immediately actionable overview for your audits and corrective actions.
Automation enhanced by human expertise
Because human expertise remains essential, certain analyses are accompanied by manual validations, which you can entrust to your own QARA auditors/consultants or delegate to our Gordios experts. Gordios also provides customized checklists to cover points that require expert judgment and structure the rest of the audit.
This gives you the optimal balance between automation and expert validation.
- Customized checklists: a tool for structuring the rest of the audit.
- Expert supplement: certain analyses trigger validation by an expert.
- Flexibility of use: complete the audit with Gordios experts or your own.
Why you can trust what it concludes
“Is your AI reliable?” is the first question a quality team asks, and it deserves mechanisms rather than reassurance. 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 manufacturers
Same platform, different starting point.
Pharmaceutical & GxP
Start with guided investigations — deviations, ICH Q9 criticality, root cause, CAPA — and check documents against your own SOPs. Built-in pharmaceutical corpora are on the roadmap; your procedures are the reference today.
Medical devices
Full automated coverage of EU MDR, ISO 13485, ISO 14971, IEC 62304 and FDA QMSR, with clause-level traceability from every finding back to the requirement it came from.
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.
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See it run on one of your own documents
Thirty minutes, your SOP, your findings. No preparation needed.