Regulatory document control that produces evidence, not verdicts
The same device is described in several places at once, and those places drift. EUDAMED records, instructions for use, label artwork and market-language versions can each look right in isolation while disagreeing with one another.
ClinicOps provides an independent reconciliation review that shows what differs, where each value comes from and what requires RA/QA judgement, without arbitrating the answer.
The failure mode is drift
Over successive revisions, translations and label updates, versions stop matching. The job is to surface those differences early, with sources attached, so the responsible team can decide which value is authoritative.
Each difference is an item of evidence to review, not a compliance finding on its own.
Document-control reconciliation review
Cross-source comparison
Compare supplied EUDAMED/UDI fields, IFU content, label artwork and market-language versions against client-approved controlled sources.
Provenance preserved
Keep revision, source and evidence context attached to each inconsistency instead of reducing the review to a red/green verdict.
Decision boundary
Where supplied sources conflict, record the issue as unresolved for RA/QA rather than silently choosing an authoritative value.
RA/QA retains sign-off
Which value is authoritative, and whether a difference matters, stays with the manufacturer's RA/QA function. ClinicOps does not approve documents or pick a winner where sources conflict; it records each inconsistency with its provenance so the team stops repeating manual cross-checks and can review, hand off and revisit version-level differences.
Identifier screening boundary
Where a review touches EUDAMED identifiers: a B-prefixed EUDAMED DI stands in place of a Basic UDI-DI under the legacy registration model, and identifier structure alone does not establish a device's regulatory state.
Typical output
- source and revision inventory;
- inconsistency register with provenance;
- unresolved-evidence list;
- recommended review sequence;
- closure fields for the responsible team.
No missing or mismatched field is treated as a standalone non-compliance finding.
Related workflows
Start with one device family or one market language
Send a small set of controlled sources, or talk through the workflow first. You get back what reconciles reproducibly, what stays unresolved and where RA/QA judgement is still needed.