Regulatory & Documentation Assurance
LabelSense reads across a device's entire document set at once — requirements, IFU, labels, standards, and design docs — to help regulatory, quality, and V&V teams author, verify, and reconcile documentation. Every output is citation-backed and human-approved.
Requirements coverage
Across 128 tracked requirements for Model RX-1 Portable Therapy Device.
Device overview
Class II · electro-mechanical with embedded software
- Docking / charging station
- Rechargeable battery pack
- Reusable patient interface module
- Sensor module
- Single-use delivery / tubing set
- Replaceable filter cartridge
- Disposable sensor pad
Recent agent activity
- Critic AgentConflict2 min ago
Flagged 1 value conflict in RX-1 Product Label (battery runtime 3.5 h vs REQ 4 h).
- Evidence AgentInfo14 min ago
Linked 6 citations to REQ-LAB-014 (Operating Temperature).
- Extraction AgentInfo1 h ago
Extracted 12 new obligations from IEC 60601-1 Ed. 3.2.
- Authoring AgentAwaiting review2 h ago
Drafted IFU §5.2 revision — awaiting human approval.
- Critic AgentAwaiting review3 h ago
Detected terminology drift: 'patient interface module' vs 'therapy applicator'.
Agent team
A coordinated team, not a monolith.
- Extraction Agent
Parses documents & standards, extracts obligations and requirements.
- Authoring Agent
Drafts labeling and IFU content grounded in the source set.
- Critic / Verifier Agent
Cross-checks drafts against requirements, standards, and other documents.
- Evidence Agent
Attaches citations and traces obligations to verification evidence.