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 labeling and registration of medical equipment. This includes devices ranging 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. A single unintentional divergence from regulations carries the potential for penalties and irreparable damage to a company’s reputation and market share.

Medical device manufacturers require labeling and barcode software solutions that are secure, proven and reliable; that fully integrate with existing systems and workflows; and 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 REGULATIONS

BarTender labeling software is the standard in medical device manufacturing, chosen by organizations ranging from Fortune 500 companies to small, specialty device manufacturers. Easily autoformat GS1 and HIBCC codes. Use the included UDI Intelligent Templates™ to connect to your master data.

MAKING COMPLEX MEDICAL DEVICE LABELS SIMPLE

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

BUILT-IN REGULATORY STANDARDS FOR TOTAL COMPLIANCE

Add accurate GS1, ICCBBA and HIBCC-compliant barcodes with a simple drag and drop. BarTender labeling software includes over 100 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 medical device label regulation, pricing or process with BarTender’s Intelligent Templates™. Edit a label’s data, format or design — updates occur immediately throughout your organization. Your medical device label is ready to print, in real time, anywhere it’s needed, throughout the world.

Support for your regulatory submissions

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

TOTAL SECURITY WITH USER ACCESS CONTROLS

BarTender’s layered security settings allow you to control who can open, edit or print a label with features from basic print-only settings, to complex role-based permissions with label format encryption.

TOTAL VISIBILITY INTO THE MEDICAL DEVICE LABELING PROCESS

BarTender labeling software lets you know who accessed a label, what edits were 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.

EASILY SETUP AND MANAGE SERIALIZATION ACROSS YOUR NETWORK

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.

REDUCE THE RISK OF ERROR WITH POWERFUL DOCUMENT DESIGN

BarTender’s new, exclusive tables feature gives you powerful document design capabilities to meet EU MDR compliance. Format IFU and implant card, group all of a product’s documents and medical device labels into one BarTender file and populate data from a single source.

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