Use case
New harmonised standard
A standard just got revised. Can you list every document in your file that references the old version?
The challenge
A revised standard is published. The clock starts. Your file now references a version that is on its way out.
Finding every reference to a superseded standard, then judging what changed and what it means for your file, is a manual sweep. It is externally driven, it arrives on someone else's schedule, and it never stops.
How our solution helps
Our AI companion "Flurina" flags the sections of your file that reference the affected standard.
It supports the gap analysis between the old version and the new one. The search becomes a list, not a hunt. You stay current without a manual sweep. The next revision is a task, not a scramble.
What it costs when the file drifts
3
rounds of harmonised-standard revisions published in under a year (Apr 2025-Jan 2026)
~15
documents per device that may reference an affected standard
10 years
the file must stay current with the state of the art
Sources: EU MDR; MedTech Europe MDR/IVDR Survey (2025)
FAQ
Any questions? We’re happy to help.
How do we find every document referencing the old version?
Point our solution at the file and it flags every affected section in one pass.
Does it do the gap analysis?
It supports it. You bring the revised standard. You make the call.
Does Flurina track new standard publications for us?
No. You bring the revised standard. Our solution "Flurina" finds every place your file still references the old one.
See where your file actually stands
Name the last standard revision relevant to your devices. Now try to list every document that still references the previous version. If you cannot do it from memory, that is the point.
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