USDM Life Sciences Teams With Inspirage to Help Medical Device Manufacturers Meet FDA's Unique Device Identifier (UDI) Compliance Regulations
USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce a teaming agreement with Inspirage to provide comprehensive consulting and technology solutions for medical device companies to meet FDA Unique Device Identification (UDI) compliance requirements.
USDM supports Life Science companies' device identification and track-and-trace programs in both the medical device and pharmaceutical industries. As part of our comprehensive offering to meet the UDI regulation, USDM has partnered with Inspirage to offer a critical component of the UDI solution, the management of product specifications. The component includes the UDI and the registration into the FDA database (GUDID).
Inspirage has developed a robust solution to help companies quickly adhere to UDI standards and build a foundation for driving value throughout the process. Legacy UDI attribute data can then be managed under FDA 21 Code of Federal Regulations (CFR) Part 11 revision control & synchronized with each stock keeping unit (SKU)/global trade item number (GTIN) to provide an auditable archive. In addition, the medical device identifier attributes associated with the "unit of use" for each product can be managed across multi-level packaging hierarchy configurations to support enterprise use of this critical data. The process then enables UDI to attribute reporting to the FDA GUDID through the FDA gateway server.
USDM and Inspirage have teamed to provide the tools necessary to meet UDI regulations, including the management of product specifications, registration of each product with the FDA GUDID and share the data with corporate production systems. Inspirage developed and implements the solution and USDM validates the implementation. The integrated process is highly efficient and comprehensive and includes a USDM developed Validation Accelerator Pack (VAP). This VAP based approach has been a hallmark of USDM's validation process and part of USDM's success in achieving a clear industry leadership position in compliance.
"The Inspirage solution is very attractive to medical device companies. Inspirage offers an immediate solution with minimal cost and time to implement. USDM is providing a unique 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 further enhance and extend our robust 3 step UDI solution by leveraging a new USDM Data Validation Pack specifically designed for this purpose."