Plan the enterprise’s UDI compliance program;
Conduct a comprehensive analysis to determine the best compliance program after fully considering the UDI requirements of the countries and regions where the enterprise’s products are sold.
Assist the enterprise to prepare the UDI control procedure;
This includes how to incorporate UDI design, application, coding rules, packaging, label presentation, and declaration to the corresponding regulatory agency database into the control procedure.
Guide the enterprise to design the UDI samples of the products
According to the structural requirements for UDI, determine the fixed and variable contents of DI and the calculation rules respectively, determine the selected PI parameters, and design the suitable UDI samples.
Guide the enterprise to declare to the corresponding regulatory agency database
For UDI that has been determined, guide the enterprise to declare to the GUDID or EUDAMED database.