Class I medical devices marked with a UPC barcode comply with the requirements of the U.S. FDA Final Rule. The UPC number is used as the UDI. For class II and II, it depends on whether the device contains additional Product Identifiers (PIs) on the label or package.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.
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