Fully integrate medical device UDI data with the registration lifecycle

Automatically generate and manage UDI information alongside other regulatory activities

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Integrate medical device UDI data with the registration lifecycle
A modern way to manage UDI data

More and more countries are implementing unique device identification (UDI) requirements for medical devices. While most are based on IMDRF guidelines, there are subtle and important regional differences. With eight different UDI systems coming online in the next few years, manually moving data to and from siloed point solutions will be time-intensive and lead to compliance risks.

Rimsys fully integrates UDI data for each country within the product registration process. Product, registration, and certificate details are captured and reflected in UDI data eliminating the need for manual transfers and ensuring that UDI data is correct and up-to-date.

Medical device UDI software from Rimsys

Automatic UDI updates
Universal UDI management

Centralize common UDI attributes across countries to prevent duplication, and reduce the likelihood of errors.

Automatic UDI updates
Country-specific UDI generation

Use Universal UDI data to auto-generate full UDI records for the EU MDR/IVDR, U.S. FDA, China NMPA, and more.

Country-specific UDI requirements
Easy UDI updates

Directly populate UDI data including expiration date, notified bodies, and classification from product, registration, and certificate records.

Electronic submissions
Basic UDI-DI records

Create and manage category-level BUDI records for EU MDR/IVDR and EUDAMED submissions.

PLM & ERP integration
PLM & ERP integration

Seamlessly access product data for registrations and UDI, and push UDI information to your ERP, CRM, and labeling systems.

Electronic submissions
Electronic transmissions

Submit UDI data directly to the U.S. FDA GUIDID, EU EUDAMED, and other systems. [coming soon]


The ultimate guide to the EU MDR/IVDR UDI

This ebook provides a deep dive into the new EU UDI requirements and EUDAMED system that were introduced as part of the MDR and IVDR regulations in the European Union.

The ultimate guide to the EU MDR/IVDR UDI
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