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.

Download the free 30-day BarTender Trial Edition to see for yourself or contact us to learn more.


Seamless integration with ERP systems like Oracle and SAP enables automation at the enterprise level, providing increased labeling accuracy while also improving efficiencies throughout the supply chain.

Control and compliance

BarTender’s centralized control connects your business data with a wide variety of printers and marking devices — whether you have one device at a single site or thousands at facilities around the world.

And BarTender provides the secure, auditable barcode and RFID technologies, including UDI’s HIBCC and GS1 symbologies and EPCglobal Gen2 encodings, that help maintain regulatory compliance and keeps the industry running.


BarTender helps meet the security demands of UDI, providing full audit trail capabilities throughout the entire labeling process. Printer-based licensing and layers of customizable settings add broad protections, with security features ranging from simple print-only settings to complex role-based permissions and label format encryption.


Regulatory and production landscapes will continue to change, and BarTender’s Intelligent TemplatesTM enable you to rapidly transform your designs, formats and processes, with support for meeting evolving interoperability standards through HL7-based UDI database (UDID) communication.

Which BarTender is right for you?

Select an edition below to learn more, or download the free 30-day trial to explore all of BarTender’s features and see how it can solve your toughest needs for labeling, barcoding and more. Or contact us to learn more about why BarTender is the most trusted software of its kind.

(Design and Print)

Basic Edition

Professional Edition

Get started in just minutes!

All Basic features, plus:

  • Design and print labels, cards, mag stripe cards and more.
  • Optimize print speed to any printer or marking device.
  • Design data-entry forms that provide data validation and accept print-time input from the keyboard or a barcode scanner.

Licensed per PC

  • Read data from CSV files, databases and Excel. Easily search and select records for printing.
  • Encode RFID labels.

Licensed per PC

Create & Automate
(Design, Print and Control)

Automation Edition

Enterprise Automation Edition

All Professional features, plus:

All Automation features, plus:

  • Automatically print from any OS, system or device in response to data transactions and SDK requests.
  • Design using Intelligent TemplatesTM to reduce maintenance.
  • Secure the printing environment with user and group roles.
  • Monitor live print status and view detailed history of system usage.

Licensed per printer

  • Print from any iOS or Android device with the BarTender Print Portal App
  • Automatically print in response to Web service API or TCP/IP communication.
  • Integrate with SAP and Oracle.
  • Take advantage of centralized system management, browser-hosted printing, centralized template storage with revision control, electronic signature support, full SDK control, smart card encoding and more.

Licensed per printer

(Please note that Print Only editions have been discontinued as of BarTender 2016.)

Related information

Regulatory Solution
UDI: Unique Device Identification 

The FDA’s compliance deadline for Class III devices has passed, and the deadline for Class II is looming. Our interactive UDI tools explain what you need to know to implement a successful UDI program: Required labeling and marking components, compliance dates, choices in AIDC and marking technologies, progress toward global harmonization.

Regulatory Solution
BarTender and FDA 21 CFR Part 11

Manufacturers operating in regulated pharmaceutical and medical device environments around the world rely on BarTender to provide the automated security, serialization, and traceability features that enable 21 CFR Part 11 validation of their labeling systems.


PDF Sheet
BarTender Software for Labeling Medical Devices

More about BarTender and medical device marking in this downloadable resource.

Case Study
Global, Multi-Facility FDA 21 CFR Part 11 Pharma Labeling

Read how BarTender transformed a highly manual set of labeling processes, increasing supply chain efficiencies and reducing exposure in a global, multi-facility CFR 21 Part 11 pharmaceutical deployment.

Industry Solution
Supply chain labeling management 

BarTender is the supply chain labeling choice of global manufacturing, distribution, transportation, 3PL and warehousing companies. Learn how BarTender can help streamline your enterprise — and help you interface more efficiently with your entire supply chain.

More Information

Regulatory Solution
UDI: Unique Device Identification

Regulatory Solution
BarTender and FDA 21 CFR Part 11

PDF Sheet
BarTender Software for Labeling Medical Devices

Case Study
Global, Multi-Facility FDA 21 CFR Part 11 Pharma Labeling

Industry Solution
Supply chain labeling management

BarTender Overview

Buy BarTender

Our Customers Say

"We evaluated several competing solutions, and found BarTender to be the best choice because of its advanced programming interface, solid reliability, exceptional support and unmatched flexibility for label design and printing. Integrating BarTender into Innovatum's ROBAR system enables the world's best label software to be used in compliance with all US and international labeling regulations."

— Ardi Batmanghelidj, President, Innovatum, maker of ROBAR label system for FDA regulated pharmaceutical, medical device, and biotechnology environments