Innovit Offers Unique Device Identification Connector Solution for FDA Compliance
SAN FRANCISCO,/PRNewswire/ -- Innovit, a global master data management solutions provider, today announced its continued commitment to medical device manufacturers on their journey to UDI compliance. Suppliers of Class III and Class II devices in America have already had to meet submission deadlines often by customizing existing applications or building custom solutions.
As they now gear up for the September 2020 deadline for Class I products, manufacturers are re-evaluating their UDI compliance strategy to move away from costly short-term solutions and adopt scalable solutions that meet global requirements. Innovit's UDI Connector enables medical device manufacturers to implement a global system and unified process that is fully integrated with internal systems to submit product data directly to FDA's Global UDI Database (GUDID).
"As regulatory compliance expands globally, medical device manufacturers are struggling with maintaining and scaling their stop-gap UDI solutions," said Bang Chau, Vice President of Business Development. "With the UDI Connector, we've already made it easy and automated for suppliers anywhere in the world to maintain FDA and UDI compliance. This will soon expand to our MDR Connector to address the European Union's regulations providing our customers a holistic path to regulatory compliance."
Innovit's UDI Connector is a GAMP5 validated and 21 CFR Part 11 compliant solution - giving suppliers and brand manufacturers a pre-packaged list of attributes, code lists and validations for submission to the FDA. Additionally, commercially sensitive data, such as listing numbers, are masked from human view and only exposed to users who have the appropriate credentials & permissions. Innovit's UDI Connector also automates the submission of UDI data using HL7/SPL standards which is the specific data format and messaging protocol required by the regulatory agency (i.e. HL7/SPL). A complete message exchange history is also stored in Innovit's solution to provide data stewards in Regulatory Affairs departments with full visibility and traceability of their data submission history.
For more information on Innovit's UDI Connector, visit: https://www.innovit.com/how-we-can-help/udi-compliance/.