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 across all countries is correct and up-to-date
UDI Data
Product-level linking

Associate and sync multi-country UDI data with product registration records for easy tracking and management

Centralized management with country-compliant record generation

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

Automatic updates

Populate UDI data including expiration date, notified bodies, and classification from product, registration, and certificate records

Basic UDI-DI support

Support EU MDR/IVDR requirements and EUDAMED submissions with category-level BUDI records

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 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

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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