Verification
Requirements-to-document coverage matrix
Every status is citation-backed. Approve results to promote them through Draft → In Review → Approved.
Illustrative demo data
Met
16
Partial
2
Not-Met
1
Unsupported
1
Filter:
| Requirement | Text | Target | Status |
|---|---|---|---|
| REQ-LAB-001 | Manufacturer legal name and address on Product Label. | Product Label | Met |
| REQ-LAB-002 | Model identifier on Product Label. | Product Label | Met |
| REQ-LAB-003 | UDI carrier (HRI + AIDC) on Product Label. | Product Label | Met |
| REQ-LAB-004 | Serial number field on Product Label. | Product Label | Met |
| REQ-LAB-005 | Electrical rating (voltage / current) on Product Label. | Product Label | Met |
| REQ-LAB-014 | Operating temperature range on Product Label and IFU. | Product Label | Partial |
| REQ-LAB-015 | Storage temperature range on Product Label. | Product Label | Met |
| REQ-LAB-018 | IP ingress-protection rating symbol on housing. | Product Label | Met |
| REQ-LAB-021 | Type BF applied-part symbol on housing near patient interface. | Product Label | Met |
| REQ-LAB-027 | 'MR Unsafe' warning + ASTM F2503 symbol on Product Label. | Product Label | Not-Met |
| REQ-LAB-030 | Intended use statement in IFU. | IFU | Met |
| REQ-LAB-031 | Contraindications section in IFU. | IFU | Met |
| REQ-LAB-033 | Any performance/outcome claim in IFU must be evidence-backed. | IFU | Unsupported |
| REQ-LAB-035 | Battery run-time claim in IFU §5.2. | IFU | Partial |
| REQ-LAB-038 | Alarm signal description in IFU. | IFU | Met |
| REQ-LAB-041 | Reprocessing / disinfection instructions for reusable surfaces. | IFU | Met |
| REQ-LAB-050 | 'Single use — do not resterilize' on delivery/tubing set. | Consumable Labels | Met |
| REQ-LAB-052 | Replacement interval on filter cartridge label. | Consumable Labels | Met |
| REQ-LAB-060 | Battery pack electrical rating on Accessory Label. | Accessory Labels | Met |
| REQ-LAB-061 | Docking station input/output rating on Accessory Label. | Accessory Labels | Met |