Cases / Medical devices · UDI
// CASE 08 · Medical devices · UDI · UDI labeling
One wrong UDI label is one compliance incident
UDI needs clear, scannable marks that match the device. Luck label software locks DI/PI and symbology in templates, with data sources and optional dedup for line and warehouse labeling.
Outcomes
01 // Diagnosis
Rules live in SOPs; labels get improvised on the floor
Breakpoints on site
- Shared vague templates omit critical data across SKUs.
- Unreadable codes or fields that don’t match registration.
- Audits can’t quickly explain how labels were printed.
How Luck label software reconnects them
- Per-model UDI templates with bound fields.
- Barcode and human-readable on one label; preview then print.
- Optional print history and approval for QA spot checks.
02 // Typical floor
How this usually runs on site
UDI needs clear, scannable marks that match registration and the device. Vague shared templates across SKUs omit DI/PI or print unscannable codes—compliance incidents at audit or customer check.
End-of-line, post-sterilization release, inbound and outbound may all trigger print; improvised fields are hard to explain to QMS. Template rules, data-driven fields, and history matter more than “it printed.”
Luck label software keeps per-model UDI templates with barcode and human-readable together; optional approval, scan dedup, and print history support audits.
03 // Label print flow
From scan to allowed print
- Confirm UDI fields (DI/PI, lot, serial, expiry, etc.) and symbology per model.
- Bind item master or work-order data into approved templates—no critical hand fills.
- Preview: human-readable matches barcode; size works with scanners.
- Print from line or warehouse via order/scan; enable dedup when needed.
- QA spot-checks scannability; reprints under permission into history.
- Optional template approval so changes pass quality roles.
- Print history keeps template version and operator for process evidence.
04 // Outcomes
Compliance · Required elements
Templates reduce missing fields.
Quality · Scannable & readable
Design and print together—fewer “prints but won’t scan.”
QMS · Process explainable
History supports internal/external audit.
05 // Label closed loop
Item master → UDI template → merge/scan print → inspect → ship
Share models and UDI fields for a device labeling plan.
Related products & solutions
What users say
Synthesized from user feedback—representative comments and impressions:
“DI/PI and symbology lock in the approved template—preview scannability, then print. Field changes go through approval with a full trail, so audits need fewer last-minute sample pastes.”
FAQ
Do you guarantee full compliance with other countries’ regulations?
We provide label printing that can lock fields/symbology and retain process history; regulatory fit must be confirmed with your registration and QMS.
How is this different from generic barcode print?
UDI stresses complete elements, scannability, and controlled change; template approval and print history are more often baseline for devices.