UDI services

• UDI strategy development — gap analysis, issuing agency selection, DI architecture, and a prioritised roadmap.
• UDI assignment — DI assignment and GTIN allocation including kits, configurable devices, and Master UDI-DI.
• UDI labeling compliance — content and format review against FDA 21 CFR 801 and EU MDR. Full guide.
• Printer qualification and design controls — remote IQ/OQ/PQ per 21 CFR Part 11.
• UDI for Highly Individualized Devices — Master UDI-DI for contact lenses, spectacle lenses, and frames.
• Data system selection — ERP, PIM, and MDM systems integrated with UDI workflows.
• Data collection and submission — FDA GUDID, EUDAMED, and global registries.
• Data maintenance and governance — change control, record updates, audit preparation.
• Staff augmentation and UDI training — embedded consultants and structured training programmes.