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, 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.
Centralize common UDI attributes across countries to prevent duplication, and reduce the likelihood of errors.
Use Universal UDI data to auto-generate full UDI records for the EU MDR/IVDR, U.S. FDA, China NMPA, and more.
Directly populate UDI data including expiration date, notified bodies, and classification from product, registration, and certificate records.
Create and manage category-level BUDI records for EU MDR/IVDR and EUDAMED submissions.
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, EU EUDAMED, and other systems. [coming soon]