Use case
Supplier component update
A supplier swaps a part. How long before you know what it does to your launch date?
The challenge
A supplier change notice arrives. Often for a small component. It was not in your plan for the quarter.
A minor part change can force revalidation and a cascade of documentation updates. By the time the full impact is mapped by hand, weeks have passed and the schedule has moved. The surprise is not the change. It is finding out late.
How our solution helps
The moment the change notice lands, our AI companion "Flurina" maps the impact across your file.
You see what needs revalidating and what documentation moves, on day one. You protect the launch date because the surprise never gets to ambush it.
What it costs when the file drifts
weeks
the usual gap between a change notice and knowing its full impact
~15
documents a single component change can force you to revisit
€ 99,648
average MDR maintenance cost per device, per year
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025)
FAQ
Any questions? We’re happy to help.
How fast do we see the impact of a supplier change?
The same day the notice lands. You get a map across the file, not a four-week surprise.
Does it flag revalidation needs?
It shows which documents and protocols the change touches, so the revalidation work is visible from day one.
Will Engineering and Quality see the same picture?
Yes. One shared view, so the handover stops being a guessing game.
See where your file actually stands
Think back to your last supplier change. How many days passed between the notice and the moment you understood the full documentation impact? That gap is the risk to every timeline.
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