Freyr has been chosen as a solution partner by BSD Medical Corp, a leading US-based medical device company, specializing in manufacturing hyperthermia systems for cancer treatment. Freyr will provide end-to-end UDI compliance solution and support for BSD Medical Corp to meet the fast approaching deadline for GUDID submissions.
Freyr will deploy “Freyr IDENTITY”, its indigenous UDI compliance solution application, to streamline, collate, compile and validate all the respective GUDID attributes and enable smoother and error-free submission. Additionally, Freyr IDENTITY will enable an efficient UDI compliance Lifecycle Management System through its advanced Data Tracking, Management, and Validation.
The project will entail in creation of a GUDID account for testing (in accordance with the FDA GUDID pre-production norms), Freyr has completed the FDA mandated test case scenarios in pre-production as required by the GUDID guidance. Post approval, it will subsequently be upgraded to a fully functional production account. Furthermore, Freyr will aid the client in identification of data attributes from various sources within the client’s infrastructure.
Freyr’s electronic submissions gateway account will be employed for the HL7/SPL submission to the GUDID database. Once the submissions have been completed, Freyr will await the ACK3 (GUDID response) for confirmation on the successful GUDID submission.