Use case
Gate review
What if gate prep took thirty minutes instead of a week?
The challenge
A design gate is coming. The team stops building and starts assembling evidence. Again.
In traditional workflows, gate prep can swallow the better part of a week of senior engineering time. That is time spent collating, not creating. Worse, a finding surfaces at the gate that should have surfaced weeks ago, and the timeline takes the hit.
What it costs when the file drifts
~1 week
of senior engineering time a single gate prep can swallow
4 months
of a year the average manufacturer spends maintaining documentation
53%
of manufacturers have cut R&D spend under the MDR/IVDR burden
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025); BAAT Medical
How our solution helps
Our AI companion "Flurina" produces a gate-readiness report mapped to your own gate checklist.
Design inputs, design outputs, V&V, transfer. It tells you what is ready and what is not, before you walk in. Prep stops being a project and becomes a quick check. The gate stops being a crisis.
See where your file actually stands
Time your team's prep on your next gate. Multiply by the gates on your roadmap this year, priced at a senior engineer's loaded rate. That is your real annual cost, measured on your own numbers, not ours.
Book a demoFAQ
Any questions? We’re happy to help.
Does it map to our own gate checklist?
Yes. The readiness report is mapped to your gates: design inputs, outputs, V&V, transfer.
How much time does it actually save?
Time your team's prep on the last gate. Most of that was collation, not judgement. That is the part this removes.
Do we have to change our gate process?
No. It fits the gates and the V-model you already run.
