Evidence & Traceability
Bi-directional trace, citation-backed and human-approved
Requirements ↔ documents ↔ standards obligations ↔ verification status. The evidence pack augments your existing PLM / ALM / QMS — it doesn't replace it.
Illustrative demo data
Requirements traced
20
Met with evidence
16
Gaps / conflicts open
9
Evidence completeness
71%
Trace matrix
Each cell is citation-backed. Gaps and conflicts are surfaced automatically.
Rows: 20 requirements · Columns: 4 document classes + linked obligations
| Requirement | Description | IFU | Product Label | Accessory Labels | Consumable Labels | Standards obligations | Verification |
|---|---|---|---|---|---|---|---|
| REQ-LAB-001 | Manufacturer legal name and address on Product Label. | — | Met LBL §1 | — | — | OBL-15223-01OBL-801-01 | In Review |
| REQ-LAB-002 | Model identifier on Product Label. | — | Met LBL §1 | — | — | — | In Review |
| REQ-LAB-003 | UDI carrier (HRI + AIDC) on Product Label. | — | Met APP §A | — | — | OBL-801-03 | In Review |
| REQ-LAB-004 | Serial number field on Product Label. | — | Met LBL §1 | — | — | OBL-MDR-03 | In Review |
| REQ-LAB-005 | Electrical rating (voltage / current) on Product Label. | — | Met LBL §1 | — | — | — | In Review |
| REQ-LAB-014 | Operating temperature range on Product Label and IFU. | — | Partial | — | — | — | Open |
| REQ-LAB-015 | Storage temperature range on Product Label. | — | Met LBL §2 | — | — | — | In Review |
| REQ-LAB-018 | IP ingress-protection rating symbol on housing. | — | Met APP §A | — | — | — | In Review |
| REQ-LAB-021 | Type BF applied-part symbol on housing near patient interface. | — | Met APP §A | — | — | — | In Review |
| REQ-LAB-027 | 'MR Unsafe' warning + ASTM F2503 symbol on Product Label. | — | Not-Met | — | — | OBL-15223-04 | Open |
| REQ-LAB-030 | Intended use statement in IFU. | Met IFU §3.1 | — | — | — | OBL-62366-01 | In Review |
| REQ-LAB-031 | Contraindications section in IFU. | Met IFU §3.4 | — | — | — | OBL-MDR-02 | In Review |
| REQ-LAB-033 | Any performance/outcome claim in IFU must be evidence-backed. | Unsupported | — | — | — | OBL-801-04 | Open |
| REQ-LAB-035 | Battery run-time claim in IFU §5.2. | Partial | — | — | — | — | Open |
| REQ-LAB-038 | Alarm signal description in IFU. | Met IFU §6.1 | — | — | — | — | In Review |
| REQ-LAB-041 | Reprocessing / disinfection instructions for reusable surfaces. | Met IFU §8.2 | — | — | — | — | In Review |
| REQ-LAB-050 | 'Single use — do not resterilize' on delivery/tubing set. | — | — | — | Met CON-TS §1 | OBL-15223-03 | In Review |
| REQ-LAB-052 | Replacement interval on filter cartridge label. | — | — | — | Met CON-FC §1 | — | In Review |
| REQ-LAB-060 | Battery pack electrical rating on Accessory Label. | — | — | Met ACC-BP §1 | — | — | In Review |
| REQ-LAB-061 | Docking station input/output rating on Accessory Label. | — | — | Met ACC-DS §1 | — | — | In Review |
Evidence Pack preview
Human-authored, AI-accelerated evidence record.
Device identity
Model RX-1 Portable Therapy Device — Class II · electro-mechanical with embedded software
Accessories: Docking / charging station, Rechargeable battery pack, Reusable patient interface module, Sensor module
Consumables: Single-use delivery / tubing set, Replaceable filter cartridge, Disposable sensor pad
Requirements coverage
16 of 20 labeling requirements Met · 2 Partial · 1 Not-Met · 1 Unsupported claim.
Standards obligations
- · IEC 62366-1 (Usability) — 3 obligations extracted, 2 linked to internal requirements.
- · ISO 15223-1 (Symbols) — 4 obligations extracted, 3 linked to internal requirements.
- · 21 CFR 801 (Labeling) — 4 obligations extracted, 3 linked to internal requirements.
- · EU MDR Annex I (GSPR – labeling) — 3 obligations extracted, 2 linked to internal requirements.
Total obligations mapped: 14.
Open contradictions (5)
- [ISSUE-1] Operating temperature range disagrees across labeling — Value conflict, High severity.
- [ISSUE-2] MR Unsafe warning missing from Product Label — Missing element, High severity.
- [ISSUE-3] Battery run-time value not propagated to Accessory Label — Propagation gap, Medium severity.
- [ISSUE-4] Cleaning / disinfection requirement specified twice — Duplicate, Low severity.
- [ISSUE-5] IFU makes a clinical-outcome claim without evidence — Unsupported claim, High severity.
Approvals log
- · 0 requirement verifications approved by reviewer.
- · 0 authored sections approved.
- · 0 conflicts adjudicated.
- · 0 obligations confirmed as internal requirements.