The FDA UDI (Unique Device Identifier) mandate was initiated to enable better traceability of medical devices throughout the supply chain and to improve the information available for managing product quality issues that could potentially impact the patient. Other global Health Authorities are also enacting similar requirements with which multinational companies will soon have to comply.
Oracle has partnered with Inspirage to deliver a UDI solution, enabling Medical Device customers to meet the imposed sunrise date.
LEVERAGING ORACLE AGILE PLM
Our UDI Solution leverages the Agile Product Collaboration (PC) application which helps enterprises achieve seamless integration of internal and external design, supply, and manufacturing data and enables management and collaboration of product record information and processes across the extended supply chain.
Inspirage helps our clients leverage the Oracle Agile PLM solutions to innovate profitably and optimize all aspects of designing, developing, launching, servicing, and disposing of products in an integrated, best-in-class model. Oracle’s Agile PLM is the industry’s most comprehensive enterprise PLM solution, and a key building block required to manage product value chains.
Inspirage client have been the first to successfully submit both pre-production data and live data on the FDA GUDID.
Global
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