UDI compliance for medical devices is not a label problem, it is a master data problem that ends at a label. We build the system that assigns your Device Identifiers, prints the Production Identifier at the line, submits records to the registries and traces an implant back to a lot.
Static Device Identifier per model, dynamic Production Identifier carrying lot, serial and expiry data.
Laser and dot-peen marking for reusable instruments that survive repeated autoclave and washer cycles.
Records prepared, validated and submitted to GUDID and EUDAMED, with status tracked per device.
Trace production, distribution, hospital receipt and implant records back to the affected lot or serial.
UDI touches regulatory affairs, product master data, the label line and the recall process. We build the data, marking, submission and traceability as one system.
✓ GS1, HIBCC or ICCBBA issuing agency structures supported
✓ DI versioning rules tied to your design change control
✓ Catalogue, model and packaging level DI hierarchy maintained
✓ Full attribute set kept ready for registry submission
✓ GS1-128 and DataMatrix AIDC with human-readable interpretation printed
✓ Laser and dot-peen direct part marking on instruments
✓ Autoclave, washer and passivation durability testing of marks
✓ Label template control with version and approval history
✓ US FDA GUDID record preparation, validation and submission
✓ EUDAMED actor, device and UDI-DI data submission and updates
✓ CDSCO medical device registration data held in one register
✓ Submission acknowledgements and rejection reasons tracked per device
✓ Lot and serial traceability from production to hospital receipt
✓ Implant card data and patient-level traceability records maintained
✓ Recall and field safety corrective action workflow with evidence
✓ Complaint and adverse event linkage to a specific lot
Marking and capture technology is chosen against the device material, the sterilisation method and the surface actually available for a mark.
Representative outcomes from medical device UDI deployments. Figures are indicative ranges typical of this solution type and must be confirmed against your own baseline before publication.
✓ Direct part marks readable after repeated autoclave cycles
✓ 60-75% reduction in manual registry data preparation
✓ Instrument set reconciliation completed by scan, not count
✓ Lot-to-patient traceability established across distribution partners
✓ Recall scope narrowed to affected lots, not whole ranges
✓ Field safety notification cycle shortened from weeks to days
✓ UDI labelling applied across the full exported catalogue
✓ 40-60% fewer registry submission rejections after validation build
✓ Label artwork errors caught before print, not after dispatch
The measures a regulatory affairs head and a QA manager will hold the project to. Targets are design goals confirmed in writing beforehand.
Share of GUDID and EUDAMED records accepted on first submission without rework.
Target: >98%
How we get there: Achieved by validating attribute sets against each registry's rules before any submission.
Readability of a direct part mark after the instrument's rated sterilisation cycles.
Target: Readable through rated cycle life
How we get there: Proven by marking parameter trials and cycle testing on your own material.
Time taken to identify every customer and consignment receiving a specific lot.
Target: Under 30 minutes
How we get there: Delivered by holding distribution events against the identifier printed on the label.
Match between printed UDI content and the approved master data record for the device.
Target: 100%
How we get there: Enforced by printing from the DI register, not from a locally held label file.
Delivery runs in stages, so regulatory deadlines and production schedules are both protected.
We review your device catalogue, classification, target markets and existing labelling, then identify which items need direct part marking and which need labels only.
Issuing agency, DI structure, label formats and marking method are fixed, and marking trials run on your own material before equipment is procured.
One product family is taken end to end, from DI assignment through marking and label print to a live registry submission, before scaling up.
Remaining families are onboarded, registry backlogs are cleared, and the system moves into an agreed annual support arrangement covering regulatory format changes.
Why device manufacturers engineer UDI as a data and marking system rather than a labelling task.
We fix the DI register and attribute governance before touching a printer, because a wrong identifier propagates into every label and registry record filed afterwards.
Laser and dot-peen parameters are trialled on your alloy and finish, then cycle-tested through autoclave and washer runs, before marking equipment is ordered.
Record preparation, validation, submission, acknowledgement and rejection handling are in scope, so your regulatory affairs head is not maintaining spreadsheets between submission windows.
The traceability model is designed against a mock recall, so a real corrective action is executed from system data instead of phone calls.
It is the requirement to give every medical device a Unique Device Identification carried on its label or directly on the device, and to register it with the relevant regulator. UDI compliance for medical devices splits into the Device Identifier, a static code identifying model and packaging level, and the Production Identifier, dynamic data such as lot, serial, expiry and manufacturing date.
No. We are a solution development and systems integration company. Every project begins with a requirement study covering your device catalogue, classification, target markets and label systems, and the DI structure, marking method and registry interfaces are engineered to that specification.
The Device Identifier is static. It identifies a model at a packaging level and changes only when the device or packaging changes. The Production Identifier is dynamic and describes the individual unit: lot or batch number, serial number, expiry date and date of manufacture.
Yes. Laser and dot-peen marking systems, print-and-apply applicators, thermal transfer printers, verification cameras and scanners are scoped, supplied, installed and integrated in the project. Marking parameters are trialled and cycle-tested on your own material before equipment is ordered.
US FDA GUDID and the European EUDAMED are both supported, with record structures and validation rules handled per registry. India’s device rules under CDSCO continue to develop, so master data is held centrally and mapped outward to each registry.
Yes. Direct part marking by laser or dot-peen is used where a label cannot survive reprocessing. We trial parameters on your alloy and finish, then cycle-test the mark through autoclave and washer runs to confirm it stays readable through rated life.
Yes. We integrate with SAP, Oracle, Microsoft Dynamics and Navision and with electronic quality management systems, so device master data, lot records, dispatch data and complaint records stay connected. Missing connectors are built within project scope.
Yes. On-premise, private cloud and hybrid deployments are all supported. Device master data and production records commonly stay inside your own infrastructure, while registry submission uses controlled outbound connections. Residency and retention terms are documented during design.
A pilot covering one product family, from DI assignment through marking and label printing to a live registry submission, is typically complete within ten to sixteen weeks of requirement sign-off, with marking equipment lead times the usual constraint.
The system moves into an agreed annual maintenance contract covering response times, preventive maintenance of marking and labelling hardware, registry format and validation rule changes, new device onboarding and mock recall support.