Automatically generate and manage UDI information alongside other regulatory activitiesRequest a demo
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.
Generate updated UDI data with each product registration. Auto-populate compliant UDI information including expiration date, notified bodies, and classification.
Access requirements and manage UDI data for the EU MDR/IVDR UDI, U.S. FDA UDI, China NMPA UDI, and more.
Seamlessly access product data for registrations and UDI, and push UDI information to your ERP, CRM, and labeling systems.
Submit UDI data directly to the U.S. FDA GUIDID, with other systems coming soon.