Use case
Design change
You changed one design output. How many other documents now say something that is no longer true?
The challenge
The change is done. Decided, committed, built. Now the rest of the file has to catch up: BOM, risk file, IFU, V&V protocols.
One design output changes and the ripple runs everywhere. Update them all by hand and one gets forgotten. The file now contains a statement that contradicts the product. That contradiction sits there until someone, often a reviewer, finds it.
What it costs when the file drifts
~15
downstream documents one design output can ripple through
50%
more spent on maintenance and re-certification over a five-year cycle
4 months
of a year spent keeping the file aligned as the product changes
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025); BAAT Medical
How our solution helps
Change ripple detection.
When a design output changes, our AI companion "Flurina" surfaces every downstream document that is now inconsistent with it. You update them on purpose, not from memory. Change once, see everything it breaks. The file stays true to the product.
See where your file actually stands
Take your most recent design change. List the downstream documents you remember updating. Now check whether anything else referenced the old value and still does.
Book a demoFAQ
Any questions? We’re happy to help.
What does it check after a design change?
The ripple. BOM, risk file, IFU, V&V, every downstream document now inconsistent with the change.
How fast do we see the impact?
As you work, not the night before a gate.
Does it touch our PLM or design tools?
No. It reads the documents in your system. No migration needed.
