01.13.14
USDM Life Sciences and Inspirage are teaming up to help medical device manufacturers meet U.S. Food and Drug Administration (FDA) Unique Device Identification compliance requirements.
The companies are working with device firms to manage product specifications, USDM and Inspirage have teamed to provide the tools necessary to meet UDI regulations, including managing product specifications, registering each product with the FDA database (GUDID) and sharing the data with corporate production systems. Inspirage developed and implements the solution and USDM validates the implementation. The integrated process includes a USDM-developed Validation Accelerator Pack.
"The Inspirage solution offers an immediate solution with minimal cost and time to implement. USDM is providing a UDI Validation Accelerator Pack that will complement this solution. The combined Inspirage and USDM solution offers broad business benefits while immediately meeting UDI industry requirements," said Kim Hutchings, USDM vice president of Alliances.
The USDM Validation Accelerator Pack and USDM ABC's for UDI Final Rule Implementation are designed to work with Inspirage's UDI solution to provide significant customer value.
"The recently announced UDI traceability mandate begins in 2014. The Inspirage Oracle UDI Solution provides a rapid framework for UDI enablement. This approach provides a scalable platform providing significant benefits and cost savings over developing custom solutions," said Jon Corbett, vice president of Inspirage. "Inspirage is now partnering with USDM to enhance and extend our three- step UDI solution by leveraging a new USDM Data Validation Pack specifically designed for this purpose."
USDM is a global regulatory consulting firm providing compliance, business intelligence, validation, qualification, quality auditing and IT services through project teams and staff augmentation to clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. The company is based in Santa Barbara, Calif.
Inspirage is a global consulting firm specializing in Oracle Supply Chain Management applications including Oracle Value Chain Planning, Oracle Value Chain Execution, and Oracle Product Lifecycle Management applications. Inspirage offers various services including business process design, implementation, and comprehensive managed services programs. Based in Bellevue, Wash., Inspirage has offices in Malvern, Pa., Europe, and India.
The companies are working with device firms to manage product specifications, USDM and Inspirage have teamed to provide the tools necessary to meet UDI regulations, including managing product specifications, registering each product with the FDA database (GUDID) and sharing the data with corporate production systems. Inspirage developed and implements the solution and USDM validates the implementation. The integrated process includes a USDM-developed Validation Accelerator Pack.
"The Inspirage solution offers an immediate solution with minimal cost and time to implement. USDM is providing a UDI Validation Accelerator Pack that will complement this solution. The combined Inspirage and USDM solution offers broad business benefits while immediately meeting UDI industry requirements," said Kim Hutchings, USDM vice president of Alliances.
The USDM Validation Accelerator Pack and USDM ABC's for UDI Final Rule Implementation are designed to work with Inspirage's UDI solution to provide significant customer value.
"The recently announced UDI traceability mandate begins in 2014. The Inspirage Oracle UDI Solution provides a rapid framework for UDI enablement. This approach provides a scalable platform providing significant benefits and cost savings over developing custom solutions," said Jon Corbett, vice president of Inspirage. "Inspirage is now partnering with USDM to enhance and extend our three- step UDI solution by leveraging a new USDM Data Validation Pack specifically designed for this purpose."
USDM is a global regulatory consulting firm providing compliance, business intelligence, validation, qualification, quality auditing and IT services through project teams and staff augmentation to clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. The company is based in Santa Barbara, Calif.
Inspirage is a global consulting firm specializing in Oracle Supply Chain Management applications including Oracle Value Chain Planning, Oracle Value Chain Execution, and Oracle Product Lifecycle Management applications. Inspirage offers various services including business process design, implementation, and comprehensive managed services programs. Based in Bellevue, Wash., Inspirage has offices in Malvern, Pa., Europe, and India.