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Medical Equipment

UDI Labelling and Device Traceability from Production to Patient Site

We implemented a Unique Device Identification (UDI) data and labelling system linked to production and distribution records. The client can now trace any device to its production lot and customer site in minutes.

Orthopaedic implants and instruments manufacturer exporting to EU and US (composite) · Medical Equipment

UDI Labelling and Device Traceability from Production to Patient Site

Challenge

Validating the system for regulated use. We delivered with computer system validation documentation (URS, risk assessment, IQ/OQ/PQ protocols) and aligned with the client's quality management system under ISO 13485.

Approach

A UDI master data service manages device identifiers, production identifiers and GS1 barcode generation, with label templates controlled through approval workflows. Data is prepared for submission to regulatory UDI databases (such as GUDID and EUDAMED) in the required formats. Scanning at packing, dispatch and distributor receipt builds a chain-of-custody record. A recall module identifies affected lots and generates customer notification lists.

Outcome

Single source of truth for UDI data and labels Faster, more targeted field safety actions and recalls Illustratively ~50–70% less manual effort preparing UDI database submissions Reduced labelling error risk through controlled templates Stronger audit readiness for notified body and regulator inspections

✓Single source of truth for UDI data and labels
✓Faster, more targeted field safety actions and recalls
~50–70%Illustratively less manual effort preparing UDI database submissions

Problem solved

Labelling data was managed in spreadsheets and label software separately from ERP, creating risk of mislabelling and slow recall response.

What we built

A UDI master data service manages device identifiers, production identifiers and GS1 barcode generation, with label templates controlled through approval workflows. Data is prepared for submission to regulatory UDI databases (such as GUDID and EUDAMED) in the required formats. Scanning at packing, dispatch and distributor receipt builds a chain-of-custody record. A recall module identifies affected lots and generates customer notification lists.

Benefits

Single source of truth for UDI data and labels Faster, more targeted field safety actions and recalls Illustratively ~50–70% less manual effort preparing UDI database submissions Reduced labelling error risk through controlled templates Stronger audit readiness for notified body and regulator inspections

UDIGS1GUDIDEUDAMEDBarcode generationCSVISO 13485

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