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 and regulatory changes are automatically 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
Automatic UDI updates

Generate updated UDI data with each product registration. Auto-populate compliant UDI information including expiration date, notified bodies, and classification.

Country-specific UDI requirements
Country-specific UDI requirements

Access requirements and manage UDI data for the EU MDR/IVDR UDI, U.S. FDA UDI, China NMPA UDI, and more.

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 submissions

Submit UDI data directly to the U.S. FDA GUIDID, with other systems coming soon.

EBOOK

The ultimate guide to the China NMPA UDI system and database

Learn about the new China UDI and labeling requirements, and the central, state-administered database for medical devices

The ultimate guide to the China NMPA UDI system and database
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