Use case
Submission readiness
The inconsistency you find at document 12 of 14 is the one that costs you the submission.
The challenge
A submission is weeks out. The file is large. Everyone is tired. This is exactly when a stale cross-reference or a mismatched intended-purpose statement slips through.
You cannot read fourteen documents against each other and stay sharp on all of them. A reviewer can. One contradiction between your device description and your risk file, and the whole file looks uncontrolled. The cost is not the fix. It is the revision cycle, the consultant time, and the delayed certification that follows.
What it costs when the file drifts
~15
documents per device must tell one consistent story under EU MDR
99,648 €
average MDR documentation maintenance cost, per device, per year
up to +49%
rise in documentation costs per device under MDR vs. the old directives
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025); BAAT Medical
How our solution helps
Our AI companion "Flurina" runs a full pass before you submit.
Cross-document consistency, structure, and traceability, all at once. Every finding comes with its source, so your team validates and decides. You stop hunting and start reviewing. You walk in knowing exactly where you stand. No surprises in the room.
See where your file actually stands
Open your last submission. Select the intended-purpose statement. Now find every place where it is referenced and check that they match word for word. Most teams find at least one that does not.
Book a demoFAQ
Any questions? We’re happy to help.
How late can we run this before a submission?
Any time, even the week before. It connects in minutes and reports where you stand.
Does it replace our final review?
No. It is what your team does before a consultant arrives. You still review and sign.
What does it catch that we would miss?
The contradictions across documents that a tired human misses at document 12 of 14. A device description that no longer matches the risk file, an intended-purpose line that drifted.
