Medical Devices
Prioritize patient safety and reduce risk
The solution at the heart of the matter.
BarTender simplifies labeling for medical device manufacturers, whether you make tongue depressors or complex life-saving equipment. When patient safety is at stake, non-compliance with regulations can result in costly penalties, harm to people, and damage to your company’s reputation. BarTender makes it easy to adhere to the latest labeling requirements with intelligent templates and configurable tools that fully integrate with your existing systems - helping you reduce risk and optimize operations.
Secure centralized control and compliance
Secure centralized control and compliance
BarTender labeling software is the standard in medical device manufacturing, chosen by companies ranging from Fortune 500 companies to small, specialty device manufacturers. Autoformat GS1 and HIBCC codes. Use the included UDI Intelligent Templates™ to connect to your master data.
Add accurate GS1 and HIBCC-compliant codes with a simple drag and drop. The standards are built-in. BarTender includes over 95 different symbologies, and supports a comprehensive list of RFID tag types and ISO standards.
Be agile to meet changes in regulation, pricing or process with BarTender’s Intelligent Templates™. Edit a label’s data, format or design — updates occur immediately throughout your organization. Your label is ready to print, in real time, anywhere in the world it’s needed.
BarTender supports evolving interoperability standards through HL7-based UDI database (UDID) communication.
BarTender’s layered security features, ranging from basic print-only settings to complex role-based permissions with label format encryption give you configurable control over who can open, edit or print a label.
BarTender gives complete visibility to the labeling process — who accessed a label, what edits they made, where and when a label was printed. Capture e-signatures and complete audit trail for compliance with global regulations, including FDA 21 CFR Part 11.
BarTender continually manages and monitors the serialization — unique, random or sequential — that drives your regulatory compliance. Increment serial numbers at a single printer or at printers across your network.
Medical device standards
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.
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
More Industries
More Industries
