Use case
Change control
When you close a change, are you certain every affected document was actually updated?
The challenge
A controlled change moves through the process. The change itself is documented. The propagation across the rest of the file is where things quietly break.
ISO 13485 expects every affected document updated and the impact assessed. Doing that by hand, across a fragmented file, means a document gets missed. Broken traceability after a change is the single largest category of audit findings. The change record looks closed. It is not.
What it costs when the file drifts
10 years
the technical file must stay consistent - 15 years for implantables, Class III
50-150K€
typical annual documentation upkeep for a Class II+ device (BAAT Medical)
70%+
of manufacturers have had to add resources just to keep the file current
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025); BAAT Medical
How our solution helps
When a controlled change lands, our AI companion "Flurina" flags every affected document.
Each finding is shown with its source. Your team confirms and updates. Nothing relies on memory. Changes close clean. Nothing left hanging for an auditor to find.
See where your file actually stands
Take your last closed change. Trace it. Was every linked document, risk control, and protocol genuinely updated? Or did one slip?
Book a demoFAQ
Any questions? We’re happy to help.
Does it fit ISO 13485 change control?
Yes. It flags every affected document so propagation is complete. You keep your controlled process.
Will it change documents itself?
No. It flags, you decide and update. Nothing is applied without you.
Can we trust it on a controlled change?
Every finding is sourced and reviewable, so it holds up in an audit.
