Medical devices
The technical file agreed with itself before the auditor asked
A medical device manufacturer pointed Cogeto at four years of technical documentation. The next morning it knew every place the file disagreed with itself, with both sentences quoted and both revisions named.
The situation
A file grown over four years and many hands
The change notice nobody propagated
A design change altered the power architecture. The specification was updated; the instructions for use were not. Two controlled documents now disagree about what an operator may do.
Audit preparation as archaeology
Weeks of engineers reading revisions side by side, building spreadsheets of what should match, and hoping the sample the auditor pulls is one they checked.
Two languages, one product
The service manual is in Croatian, the specification in English. No reviewer reads both at once, so cross language disagreement is invisible by construction.
The run
The run
One bulk import: the technical file as it stood, including scanned type test reports and spreadsheet based risk tables.
- 1412 documents imported in one operation, deduplicated by content
- 2Scans read by local recognition inside the instance
- 3Every document anchored to its product, class, and revision
- 4Every extracted claim verified against its own source sentence
- 5Overnight reconciliation across the whole corpus
The findings
The findings
Four of the twenty seven, as the product reports them.
The change notice conflict: the manual still permits what the current specification forbids.
A numeric conflict caught by arithmetic: the type test never covered what the specification requires.
A cross language finding: the Croatian service manual and the English datasheet describe different hardware.
A supersession kept as history: shelf life changed by change notice, and the chain shows when belief changed.
Then you ask.
Can the battery be changed during operation? The instructions for use permit it. The current specification forbids it: any supply interruption requires full re-initialization. Conflict: a change notice altered the power architecture; the manual was never updated. Stands on: IFU r4, Spec rF, change notice.
What was the sterile shelf life when the March lot shipped? Three years at that date, per the labeling specification then in force; tightened to two years by change notice CN-0142 since. Stands on: Labeling spec rC, CN-0142.
What it means for you
What it means for you
Audit preparation in days
The findings report over the exact file scope, signed, with every conflict and its evidence, goes into the design review record.
Conflicts caught on creation day
Every new change notice is checked against everything already known the day it arrives, not at the next audit.
History that survives turnover
Superseded statements keep their chains, so what the file asserted at any date stays answerable.
Answers with citations
Ask the file anything; every claim in the answer names its sentence, document, and revision, or says the file is silent.
Cogeto produces evidence about your documents. Regulatory judgment stays with your organization.
Run it where your material lives
- Hosted in the EU: your single tenant instance, operated for you.
- Your cloud: deployed inside your own infrastructure.
- Fully offline: local models, no outbound connectivity, no telemetry.
First questions
Is this a regulatory assessment?
No. Cogeto produces evidence about your documents: what conflicts, what superseded what, and what could not be verified. Regulatory judgment stays with you.
Our file is full of scans. Does that work?
Scanned pages are read by local recognition inside the instance, so nothing leaves your boundary. Pages that cannot be read are listed by name, never silently skipped.
Our documentation is in two languages.
Subjects resolve across languages, so a Croatian manual can contradict an English specification. Accuracy is measured and published per language, so you see the quality before you commit.
Who resolves the findings?
Your engineers, with both sentences and both revisions in front of them. Cogeto surfaces and documents; it does not decide which document is right.
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