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Neleus Medical
For medical devices that carry software. One technical file that answers the Medical Device Regulation and the EU AI Act together, instead of two projects that contradict each other.
In design
The problem it is being designed for
A device that carries software now sits under two regimes at once. The MDR asks for a technical file and a quality system. The AI Act asks for its own technical documentation, risk management, data governance and human oversight. The two overlap heavily in substance and not at all in vocabulary, so most teams run them as two projects and reconcile them by hand at the worst possible moment.
The design goal is one spine underneath both: a single set of governed records that produces the MDR technical file and the AI Act documentation from the same evidence, with the overlap mapped rather than duplicated.
Why we think we can build it
The company behind Neleus was founded and sold by someone who ran a medical device business and drove its ISO 13485 quality system himself. This line is not an adjacent market we noticed. It is the problem we already lived through, built properly this time.
What exists today
- The governed vault, the two locks and the evidence chain, shared with Neleus GRC.
- A written scope for the MDR and AI Act mapping, held in our own governance system.
- No medical framework library, and no conformity workflow. Both are design work, not shipped work.
Talk to us early.
A line in design is the moment your requirements can still shape it. If you carry a device with software in it, thirty minutes now is worth more than a demo later.