A recent press release states, “Innovit, a global master data management solution provider, today announced the availability of its Unique Device Identification (UDI) Multi-Connector solution, which helps medical device manufacturers keep pace with regulatory compliance standards and reduce the threat of counterfeiting by automating UDI data submissions to a host of regulatory databases. Innovit’s UDI Multi-Connector helps global medical device manufacturers manage and automate the submission of UDI data using the HL7 SPL data format and messaging protocol required by the FDA and proposed by the EU Commission. Innovit also stores a complete message exchange history, which provides organizations with full visibility and traceability of their data submission history.
The release continues, “Organizations that have developed their own in-house UDI submission systems face the enormous cost of maintaining, upgrading and validating these systems to GAMP5 standards. The upcoming MDR requirements for Europe, which will require support for multi-lingual data, registration and clinical documentation, will impose an enormous development and re-validation cost burden. Innovit’s UDI Multi‑Connector allows global medical device suppliers to achieve compliance with UDI requirements while reducing operational, SQA and other IT costs. This UDI solution is offered in conjunction with Innovit’s PIM solution, and available through hybrid, public and private cloud hosting options.”
Read more at PR Newswire.
Photo credit: Innovit