LabelSense
Contradiction Radar

Cross-document conflict detection

Scanning across 12 documents simultaneously — requirements, IFU, product / accessory / consumable labels, and applied standards.

Illustrative demo data
Cross-document scan
Critic + Evidence agents cooperate to detect value conflicts, missing elements, propagation gaps, duplicates, and unsupported claims.
5 open
5 total detected
High severity
3
Medium severity
1
Low severity
1
Type:
Severity:
ISSUE-1Value conflictHigh severityOpen
Critic Agent · Evidence Agent

Operating temperature range disagrees across labeling

RX-1 Requirements Specification
REQ-LAB-014
“The device shall be labeled with an operating temperature range of 15 °C to 35 °C.”
RX-1 Instructions For Use
IFU §7.4
“Operate the device between 10 °C and 40 °C ambient temperature.”
RX-1 Product Label
LBL §2
“Operate 10–40 °C. Store −20 to 50 °C.”
Why this matters

Labeling documents state a wider operating range than the approved requirement. Field use at 10–14 °C or 36–40 °C would exceed validated conditions and constitute off-label operation.

Suggested resolution — Align IFU §7.4 and Product Label §2 to 15 °C–35 °C, or open a change request against REQ-LAB-014 with supporting environmental test evidence.
Human adjudication required · nothing changes automatically
ISSUE-2Missing elementHigh severityOpen
Critic Agent · Evidence Agent

MR Unsafe warning missing from Product Label

RX-1 Requirements Specification
REQ-LAB-027
“The Product Label shall bear the statement 'MR Unsafe — do not use in MRI environment' with the corresponding ASTM F2503 symbol.”
RX-1 Instructions For Use
IFU §2.3
“MR Unsafe. Do not use the Model RX-1 in an MRI environment.”
RX-1 Product Label
LBL §1–3
“(no MR Unsafe statement or symbol present)”
Why this matters

A required safety warning is present in the IFU but omitted from the Product Label. The label is the point-of-use artifact — omission creates a foreseeable use hazard.

Suggested resolution — Add the 'MR Unsafe' text + ASTM F2503 symbol to Product Label §1 header block. Re-verify against REQ-LAB-027.
Human adjudication required · nothing changes automatically
ISSUE-3Propagation gapMedium severityOpen
Critic Agent · Evidence Agent

Battery run-time value not propagated to Accessory Label

RX-1 Instructions For Use
IFU §5.2
“A fully charged battery pack supports up to 8 hours of continuous therapy.”
Battery Pack Label
ACC-BP §1
“Li-ion 14.4 V · 4400 mAh. Rated runtime up to 6 h.”
Why this matters

The IFU was revised to reflect the extended-capacity cell, but the accessory label was not updated. Clinicians reading the label will underestimate available runtime.

Suggested resolution — Republish Battery Pack Label at v1.3 with '8 h' runtime; run cross-label sync check for any other affected artifacts.
Human adjudication required · nothing changes automatically
ISSUE-4DuplicateLow severityOpen
Critic Agent · Evidence Agent

Cleaning / disinfection requirement specified twice

RX-1 Requirements Specification
REQ-LAB-014
“Labeling shall provide cleaning and low-level disinfection instructions for the patient interface module.”
RX-1 Requirements Specification
REQ-LAB-041
“The IFU shall include reprocessing instructions covering cleaning and disinfection of reusable surfaces.”
Why this matters

Two active requirements cover overlapping scope with slightly different wording. Traceability and verification effort are duplicated, and the two lines could drift apart over time.

Suggested resolution — Merge into a single normative requirement (retain REQ-LAB-041); mark REQ-LAB-014 clause as superseded with a redirect note.
Human adjudication required · nothing changes automatically
ISSUE-5Unsupported claimHigh severityOpen
Critic Agent · Evidence Agent

IFU makes a clinical-outcome claim without evidence

RX-1 Instructions For Use
IFU §3.1
“The Model RX-1 is clinically proven to improve patient outcomes.”
RX-1 Requirements Specification
—
“(no requirement authorizes this claim; no linked clinical evidence)”
Why this matters

A comparative clinical benefit claim without underlying requirement or evidence is a regulatory-risk statement (21 CFR 801, EU MDR Annex I §23).

Suggested resolution — Either remove the sentence from IFU §3.1, or open a new requirement and attach clinical evaluation evidence before re-approving.
Human adjudication required · nothing changes automatically