SANTA BARBARA, Calif.--(BUSINESS WIRE)--QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of cloud enterprise resource planning (ERP) solutions and services for global manufacturers, announced today it has developed a solution for medical device manufacturers to help meet the Unique Device Identifier (UDI) rules as required by the Food and Drug Administration (FDA).
The FDA issued a rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier, except where the rule provides for an exception or alternative placement. The labeler must also submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID). The first phase of the UDI requirements applies to class III devices and requires that they display the UDI label by September 24, 2014. The UDI labels include a device identifier, which consists of the labeler and specific model of the device, and a production identifier that includes lot or batch numbers, expiration date and other valuable information.
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