BarTender® Software for Medical Device Labeling and Marking

Global regulatory agencies such as the US FDA and the European Commission are enacting strict policies for the labeling and registration of every single piece of medical equipment, from simple tongue depressors to complex life-saving technologies.

With patient safety at the core of these unique device identification (UDI) regulations, there is no room for compromise: Even the smallest unintentional divergence from the rules carries potential penalties and irreparable damage to a company’s reputation and market share.

Medical device manufacturers require labeling solutions that are secure, proven and reliable; that integrate completely with existing systems and workflows; and that can scale and adapt to evolving business practices.

BarTender is the heart of your compliance labeling solution.

BarTender® software is a secure component of FDA-compliant UDI installations around the world. The medical device industry chooses BarTender for its ease of deployment and configurable technology, all backed by industry expertise — we understand the regulatory and process pressures medical device manufacturers face.

Built for UDI and MDR

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.

Simple. And sophisticated

BarTender is both easy to use, and a powerful tool for even the most complex labels, in the most demanding regulatory environments.

We comply with the standards for you

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.

Global change management in an instant

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.

Support for your regulatory submissions

BarTender supports evolving interoperability standards through HL7-based UDI database (UDID) communication.

Control roles and access for compliance

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.

You need to know who edited or printed your labels. Every time

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.

Set up serialization across your network, and then forget about it

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.

EU MDR compliance: format IFU and implant card, and then connect them with packaging and labeling

BarTender’s new, exclusive tables feature gives you powerful document design capabilities. Group all of a product’s documents and labels into one BarTender file and populate data from a single source, reducing the risk of human error.

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