unique device identifier (UDI)
UDI compliance made easy
Achieve seamless compliance with Unique Device Identifier (UDI) standards. BarTender is designed to drive labeling compliance in FDA- and EC-validated installations at medical device companies around the world.
Meet regulatory requirements efficiently and accurately
Comprehensive UDI label design
Create UDI-compliant labels effortlessly. BarTender ensures that all necessary UDI elements, such as device identifier (DI) and production identifier (PI), are included on your labels and provides pre-built label templates for even faster label design.
UDI data integrated with labeling
Minimize errors and maintain consistency. BarTender integrates seamlessly with your existing data sources (ERP, MES, and other databases), ensuring accurate and up-to-date information is used in your labels.
UDI standards compliance
Stay ahead of regulatory changes. We support the latest UDI standards and regulations from the FDA and EU MDR, providing you with a reliable tool to maintain compliance as regulations evolve.
Advanced serialization and traceability
Ensure each individual device is uniquely identified and traceable. BarTender supports various serialization formats and schemas required by regulatory bodies, allowing you to keep track of all moving assets.
Validation and audit support
Simplify validation and audit processes with comprehensive logging and reporting. Track and document every step of your labeling process to verify UDI requirements are consistently met, providing clear evidence of compliance during inspections or audits
Ready to simplify your UDI compliance?
Streamline your labeling process to meet UDI standards efficiently and accurately. Contact us today to learn more and see how BarTender can support your compliance needs.