ClinicOps
Sanitized prototype · browser-local

Does your technical documentation agree with itself?

The same fact — device name, UDI-DI, intended purpose, shelf life, software version — appears in the Declaration of Conformity, label, IFU, technical file summary, SS(C)P and registration data. When those copies drift apart, reviews stall. Paste each key value as it appears in up to five sources and get a deterministic, severity-banded divergence report with an evidence queue.

Runs locallyDeterministic normalization rulesVerbatim values preservedPortable JSONHuman authority preserved
Method boundary. This is a sanitized demonstration of a working method using fictional example data. It compares only the values you paste, exactly as you paste them — it does not review your documents, it never decides which value is correct, and it is not a compliance determination or regulatory advice. Deciding which source is authoritative and whether a divergence matters is a human decision for your regulatory reviewer.

1 · Name the sources

Columns set to "— none —" are excluded. Mark a cell "n/a" when that document legitimately does not carry the fact; leave it empty only when the value should exist but you have not observed it.

2 · Paste each value as printed

Consistency report

Run the check to see divergences, severity bands and the evidence queue.

NOT RUN
0critical conflicts
0major findings
0minor / cosmetic
0informational
FieldFindingSeverityDetail
No check run yet.

Evidence queue

  1. No queue generated yet.

The tool never says which value is correct. For each divergence: identify the controlled source-of-truth document, confirm the approved value with its owner, route the correction through change control, correct every divergent instance, then re-run the check.

Export & handoff

The copied summary carries only the band, counts and divergent field names — never your pasted values, which may be confidential. The downloaded JSON contains the full grid for your own records.

Verbatim preservedNormalization ("N-200" vs "N200", "(01)" wrappers, "2 years" vs "24 months") only classifies; your pasted text is never altered in the report.
Fail-closedOne source cannot corroborate itself. Different unit families are flagged for manual verification, never auto-equated across families.
Human-ownedFindings route review work. Which value is correct — and whether it matters under MDR/IVDR — stays with your qualified owner.

From pasted values to a reviewed technical file

This check demonstrates the smallest unit of the method: one fact, several documents, a deterministic verdict on whether the copies agree. A scoped review applies the same discipline across a full technical-documentation set with named owners, evidence references and a reviewer-ready closure packet.

Scope a consistency reviewCheck one change's propagationMap a regulatory change's impactEmail info@clinicops.dk