Use case
Impact assessment
Before you commit to a change, do you actually know what it will cost you in documentation?
The challenge
A change is on the table. Someone has to say yes or no. The engineering cost is easy to picture. The documentation cost is invisible until later.
There is no single source of truth for what depends on what. So you commit, then discover the change touched seven documents you did not plan for. The estimate was wrong because half the work was hidden.
How our solution helps
Point it at a proposed change
Our AI companion "Flurina" shows you which documents would become inconsistent if you went ahead. You see the blast radius before you commit, not after. You decide with your eyes open. Assessment in minutes, not days.
What it costs when the file drifts
~15
documents a single change can silently touch
50%
more is spent on maintenance and re-certification than on initial certification
4 months
of a year the average manufacturer spends maintaining documentation
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025)
FAQ
Any questions? We’re happy to help.
Can it assess a change before we commit?
Yes. It shows which documents a proposed change would make inconsistent, before you decide.
How does it know what depends on what?
It reads the relationships across the file in your system e.g. SharePoint. No manual dependency map to build.
What if it misses something?
Every finding is sourced and you validate it. It is built for MedTech documents, not a general tool.
See where your file actually stands
Take a change you are weighing right now. Write down every document you think it touches. We will bet you miss at least half.
Book a demo
