Deterministic Verification
for MDR/IVDR
Documentation
Catch unsupported claims, weak evidence links, numerical mismatches and cross-document gaps before Notified Body review.
Our Offer
One Audit Across Your MDR/IVDR Evidence Package
Start with one CER or PMCF package. Receive a claim-to-source audit in 5 business days.
CER
PMCF
PMS / PSUR
SSCP
GSPR
NB
Responses
How it works
Finding ECO03 — Critical
Claim overstates PMCF support: cited
section confirms safety monitoring, but
does not demonstrate clinical benefit
in the target population.
Clinical Evidence Gaps
Insufficient evidence for an intended purpose, indication, population, device variant, or benefit-risk conclusion.
AI Agent
Unsupported claims
Claims that are not sufficiently backed by the cited clinical, scientific or post-market evidence.
The primary endpoint, defined as the proportion of patients achieving a ≥50% reduction in total score from baseline at Week 24, was met. In the intent-to-treat (ITT) population (n=312), 68.4% of patients in the Compound X arm achieved the primary endpoint compared to 31.2% in the placebo arm (p<0.001). The between-group difference was 37.2 percentage points (95% CI: 29.8–44.6).
Cross-document gaps
Misalignment between CER, PMCF, PMS, SSCP, GSPR mappings or NB response materials.
Comparison
CER v4
92.4%
PMCF v2
81.7%
Numerical inconsistencies
Conflicting percentages, totals, dates, thresholds, population counts or study figures.
CER_14.1_v1.docx
PMCF_14.2_v2.pdf
SSCP_16.2_v1.docx
Outdated references
Stale sources, obsolete tables or evidence that no longer matches the current version of the document.
Weak evidence links
Statements where a source is cited, but the source does not clearly support the exact claim being made.
Our Process
Our Engagements
Designed for Sensitive Regulatory Documents.
We handle sensitive regulatory documents with confidentiality, and a deliberately limited scope.
No model training
Client documents are not used to train shared models. Pilot scopes can include contractual deletion/retention limits, separated workspaces, and controlled processing options.
Redacted pilot available
Start with a redacted CER/PMCF package or a synthetic sample.
No platform rollout
Start with one bounded audit.
Human judgment preserved
LocusLab surfaces evidence issues for expert review. Your RA, clinical or QA team remains in control of the final judgment.
