Inventory & traceability
UDI
Unique Device Identification
FDA-mandated unique ID on every medical device — submitted to GUDID.
Unique Device Identification (UDI) is the FDA requirement (21 CFR 830) that every medical device carry a unique identifier on label and packaging, with the device identifier portion (DI) submitted to the Global UDI Database (GUDID). EU MDR has an equivalent (UDI-DI + Basic UDI-DI in EUDAMED). V5's eDHR prints and verifies the UDI on each device at the labelling step.
Regulatory anchors
- 21 CFR 830
- EU MDR Article 27
How V5 handles it
Lot traceability — recall in minutes, not weeks.
V5 captures the lot link at every point of consumption, so the trace is a query — not a war room.
Labels — designed, approved, printed and audited in one place.
Most regulated manufacturers run a label tool (NiceLabel, Loftware, BarTender) bolted next to their QMS — versions drift, reprints aren't audited, and 211.122 / 111.130 / 820.120 findings follow. V5 puts the designer, the approval workflow, the print agent and the reprint audit trail in one place — the same place that holds the BMR.