Rimsys UDI

Integrated and automated UDI management

Manage UDI data and database submissions within the product registration lifecycle

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UDI Management
Eliminate manual updates and ensure that UDI data for all products and packaging is correct and up-to-date
UDI Data
Product-level linking

Associate and sync country-specific UDI data with product registration records for easy tracking and updating

Centralized management with country-level synching

Manage top-level UDI information and auto-generate country-compliant formats for the U.S., EU, China, Korea, and more

Automatic updates

Auto-populate UDI data including expiration date, notified bodies, and classification as product details change

Electronic submissions

Submit UDI data directly to health authority databases to eliminate manual duplication and submission errors

ERP, CRM and labeling system integration

Push UDI information and ensure consistency across your ERP, CRM, PLM, and labeling systems

BLOG
Quick reference guide - global medical device UDI requirements and timelines

Keeping track of country-specific UDI requirements, timelines, and affected devices can be a big challenge to RA teams. This guide consolidates timeline information and device class requirements across multiple regions (China, EU, India, Japan, Korea, Saudi Arabia, Singapore, Taiwan, and US)

Quick reference guide - global medical device UDI requirements and timelines

Integrate UDI data within the product regulatory lifecycle

Product registration

Create, monitor, and manage global registrations and regulatory applications

Essential principles

Create and maintain essential principles/general safety and performance requirements (GSPR) tables

Regulatory intelligence

Track relevant laws, regulations, guidance, and news

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