SAN 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 InnovitInnovit's globally certified product master data management solutions protect revenue streams, reduce supply chain costs, improve online product marketing effectiveness and ensure regulatory compliance. Delivering the fastest time to value for a complete end-to-end solution, Innovit provides preconfigured modules that have out-of-the-box data validation, the broadest global coverage for data synchronization, and publication capabilities that offer maximum syndication advantage for omni?channel commerce. Operating since 2000, Innovit is based in San Francisco CA with offices in London, Sydney and Melbourne and serves customers such as Johnson & Johnson, Kellogg's, 3M, Colgate Palmolive and B. Braun across diverse industries including healthcare, CPG, industrial supply and distribution.
Media Contact:
Michael GalloLumina [email protected] 212-239-8594
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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.
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"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 InnovitInnovit's globally certified product master data management solutions protect revenue streams, reduce supply chain costs, improve online product marketing effectiveness and ensure regulatory compliance. Delivering the fastest time to value for a complete end-to-end solution, Innovit provides preconfigured modules that have out-of-the-box data validation, the broadest global coverage for data synchronization, and publication capabilities that offer maximum syndication advantage for omni?channel commerce. Operating since 2000, Innovit is based in San Francisco CA with offices in London, Sydney and Melbourne and serves customers such as Johnson & Johnson, Kellogg's, 3M, Colgate Palmolive and B. Braun across diverse industries including healthcare, CPG, industrial supply and distribution.
Media Contact:
Michael GalloLumina [email protected] 212-239-8594
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SOURCE Innovit
