Integrated and automated UDI management
Manage UDI data and database submissions within the product registration lifecycle
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Associate and sync multi-country UDI data with product registration records for easy tracking and management
Manage top-level “Universal” UDI information and auto-generate country-compliant formats for the U.S., EU, China, Korea, and more
Populate UDI data including expiration date, notified bodies, and classification from product, registration, and certificate records
Support EU MDR/IVDR requirements and EUDAMED submissions with category-level BUDI records
Submit UDI data directly to health authority databases to eliminate manual duplication and submission errors
Push UDI information and ensure consistency across your ERP, CRM, PLM, and labeling systems
Keeping track of country-specific UDI requirements and timelines is a big challenge for RA teams. This guide consolidates timeline information and device class requirements across multiple regions, including the US, EU, China, Japan, Brazil, Australia, Canada, India, Saudi Arabia, Singapore, Taiwan
Integrate UDI data within the product regulatory lifecycle
Create, monitor, and manage global registrations and regulatory applications
Create and maintain essential principles/general safety and performance requirements (GSPR) tables
