Label printing done right. Validated. Verified.
Compliant UDI label design, label printer and BarTender setup, IQ/OQ/PQ validation packages, and label checks against your GUDID and EUDAMED records, all from one team.
Your label, decoded
Your label is part of the device.
A label that is wrong, unreadable, or out of sync with your device database is not a cosmetic problem. A labeling error can mean misbranding, a recall, or an audit finding, and every one of those starts at the printer.
United States · FDA
- 21 CFR Part 801: the label must carry a UDI in plain-text and AIDC (barcode / Data Matrix) form.
- 21 CFR Part 830: device identifier data goes to the FDA's GUDID and must match the label.
- QMSR (21 CFR Part 820, in effect since Feb 2, 2026): brings in ISO 13485:2016, including validation of production software and processes.
European Union · MDR / IVDR
- UDI carriers are required on labels, with Basic UDI-DI and UDI-DI data registered in EUDAMED.
- The EUDAMED registration deadline is November 28, 2026. Label data and EUDAMED records have to agree.
- A manufacturer needs an actor registration (SRN) before it can register any devices.
Where label risk really comes from
Unreadable barcodes
Worn print heads, the wrong print-quality mode, or media that doesn't suit the printer produce Data Matrix codes that fail at the scanner.
Data mismatches
The DI, model number, or device description on the label no longer matches GUDID or EUDAMED after a change.
Unvalidated systems
A printer and labeling software in production use with no IQ/OQ/PQ evidence is an easy audit finding.
Uncontrolled templates
Anyone can edit a template, with no version history, approvals, or locked fields.
Wrong production data
Lot, expiry, or serial numbers keyed in by hand, skipped, or duplicated across a batch.
No reconciliation
Printed, used, and voided labels are never counted, so loose labels end up on the wrong product.
Everything from the label template to the database record.
We cover the whole labeling chain: the data behind the UDI, the template that lays it out, the printer that puts it on media, and the validation evidence that proves the process works.
Compliant label design
UDI-compliant layouts with the DI and PI in human-readable and AIDC form, GS1 / HIBCC / ICCBBA syntax, symbols, and the regulatory content required for the US and EU markets.
Label template setup
Templates built in BarTender or similar tools: database-linked fields, serialized and incrementing data, Data Matrix and QR objects, locked layouts, and a controlled template library.
Label printer setup
Installing and configuring industrial label printers such as the Epson ColorWorks series: drivers, connectivity, media and print-quality settings, cut and stop modes, and admin lock settings.
IQ / OQ / PQ validation packages
Ready-to-execute protocols, test sheets, deviation logs, and a summary report for the label printer and the labeling software together.
Label checks vs. GUDID / EUDAMED
Field-by-field checks that the printed label (DI, brand, model, size, sterile and MRI status, and more) matches the data you have submitted or plan to submit.
UDI assignment
Structuring your Basic UDI-DI, UDI-DI, and packaging-level DIs, and choosing which production identifiers (lot, serial, expiry, manufacture date) go on each label.
Data collection & submission
As a registered third-party data collector and submitter, we gather, validate, and submit your device data to GUDID and EUDAMED.
Opening EUDAMED accounts
Actor registration and SRN, user access, and getting you ready to register devices ahead of the November 28, 2026 deadline.
Installed right. Works right. Prints right. Every time.
The printer and labeling software are qualified together in three phases. The printer is released for medical-device labeling only after all three pass.
Each phase has its own protocol, acceptance criteria and sign-off, and must be approved before the next one starts.
WHAT WE VERIFY
- Equipment and component identification, checked against the packing list
- Power, surface, clearance, and facility checks (with a multimeter)
- Correct ink cartridges and maintenance box for the model
- Maintenance tasks added to your maintenance system
- Driver and BarTender installation, licensing, and connectivity
- Documentation under control (SOPs, manuals)
- Health, safety, and environment: temperature, humidity, guards, caution labels
Each phase has its own protocol, acceptance criteria and sign-off, and must be approved before the next one starts.
WHAT WE VERIFY
- USB, LAN, and Wi-Fi connectivity, including loss and recovery
- Touchscreen and panel functions, error messages
- Nozzle check, head cleaning, and maintenance functions
- Media loading, detection, and sensor calibration
- BarTender: Data Matrix and QR scan, serialization, batch counts, job cancel
- Cutter and stop modes, cut-position tolerance
- Print position, colour correction, admin lock and password
- Each print-speed and quality mode passes the label QC check
Each phase has its own protocol, acceptance criteria and sign-off, and must be approved before the next one starts.
WHAT WE VERIFY
- Settings fixed and locked at the optimum confirmed in OQ
- Three consecutive production-representative batches per label type
- 100% content match against the master data record
- Every barcode / Data Matrix scans first time and decodes correctly
- No print-quality drift from the first label to the last
- Label adhesion and application on the real device
- 100% label reconciliation and traceability
Aligned with ISO 13485:2016, the QMSR, 21 CFR Part 11, ISO 14971 and the GAMP 5 risk-based approach.
1 printer. 3 protocols. 22 tests.
What a typical validation package covers for an Epson ColorWorks CW-C4000-class printer running BarTender, with example acceptance criteria from our protocols. Tap a test area to open it.
Built-in deviation control
Every test ends with "Acceptance criteria met: YES / NO". Any NO is logged as a deviation and assessed before the summary report is signed.
Tailored to your setup
Label types, batch sizes, media, connection method and colour pipeline are set to match how your site actually prints.
Free blank templates
Download our blank IQ, OQ and PQ protocols from the resource library.
IQ 1–3Identification · Facility & electrical · Consumables
IQ 4–6Maintenance · Software install & connectivity · Documentation
IQ 7Health, safety & environment
OQ 1–4Connectivity · Panel · Maintenance functions · Media handling
OQ 5Labeling software (BarTender)
OQ 6–10Cutter & stop modes · Utility & driver config · Print position · Colour · Security
OQ 11–12Variable data · Speed & quality modes · Optimization
PQ 1Print quality, content & scan verification
PQ 2Adhesion & application
PQ 3Reconciliation & traceability
Five steps from "is this compliant?" to "released for use."
A documented path with a defined output at every step, so your QA team always knows where the project stands.
Assess
We review your current labels, templates, printer, software, SOPs, and the GUDID / EUDAMED data you have or plan to submit. We find the gaps: missing UDI elements, unreadable symbols, uncontrolled templates, and missing validation evidence.
Set up
We design or correct label layouts, build database-linked templates in your labeling software, assign or confirm your UDI-DIs, and configure the printer's media, quality, cut, and security settings.
Validate
We write and support execution of the IQ, OQ, and PQ protocols for the printer and software together, from installation checks through three-batch production runs, managing deviations along the way.
Verify against GUDID / EUDAMED
We compare printed labels field by field with your device records and, as your registered submitter, collect, correct, and submit that data so the label and the database say the same thing.
Hand off
We hand over everything your team needs to run it: template change control, a routine QC check, reconciliation, maintenance schedules, and triggers for revalidation.
The labeling checklist we use on every project.
Best practices from the field, plus the five mistakes we catch before your auditor does.
Label content & UDI
- Put the UDI in both human-readable and AIDC form, generated from the same data source
- Use your issuing agency's syntax (e.g. GS1 Application Identifiers) correctly
- Include only the production identifiers you actually control
- Give each packaging level its own DI and quantity
Templates & software
- Link templates to a controlled data source, not hand-typed text
- Lock layouts; restrict who can edit, approve, and print
- Version-control templates and keep an approved master library
- Test serialization: no skipped or duplicate values
Printer & media
- Use only the specified consumables and qualified media
- Keep the printer in its rated temperature and humidity range
- Schedule nozzle checks and head cleaning
- Replace the default admin password and lock panel settings
Verification & control
- Scan every symbol and compare decoded data with the master record
- Grade print quality with an ISO/IEC 15415 / 15416 verifier
- Reconcile printed, used, and voided labels on every run
- Revalidate after any change to printer, firmware, software, media, or template
5 common labeling mistakes
Is your labeling audit-ready?
Book a free 15–30 minute video consultation call. Our team will review your labels, printer and software setup, validation evidence and GUDID / EUDAMED readiness, and identify the gaps.
Book a Free Video ConsultationNo obligation. You get a list of the gaps we find, recommended next steps and a clear scope if you want our help.
