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Innovit Helps Medical Devices Manufacturers Meet Regulatory Compliance, Reduce Counterfeiting with UDI Multi-Connector ProductSAN FRANCISCO, June 12, 2018 /PRNewswire/ -- 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 adoption of UDI and MDR policies around the world presents a major challenge for global medical device manufacturers trying to understand and comply with this flurry of regulations," said Bang Chau, Vice President of Business Development. "Innovit's UDI Multi-Connector overcomes these challenges by allowing device manufacturers to implement a 'global system and unified process' that is fully integrated with internal systems." For the FDA's GUDID (Global Unique Device Identification Database) requirements, Innovit's system is GAMP5 validated and fully compliant with 21 CFR Part 11 requirements. 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. For more information on Innovit's UDI Multi-Connector solution, visit here: http://www.innovit.com/how-we-can-help/udi-compliance About Innovit Media Contact: Michael Gallo View original content:http://www.prnewswire.com/news-releases/innovit-helps-medical-devices-manufacturers-meet-regulatory-compliance-reduce-counterfeiting-with-udi-multi-connector-product-300664272.html SOURCE Innovit |