Medical Device Labeling


A comprehensive FDA-compliant UDI labeling
solution for medical device manufacturers

Medical Device


The key challenges that medical device manufacturers confront today include an ever-changing FDA’s UDI and EU’s MDR regulations, as well as cost management and business operations. With possible hazards to the healthcare industry, enterprises must ensure that they are in compliance with the existing regulations in the source country.

Medical Device Labeling, a digital platform from LabelingOnUs, is particularly intended to suit the specific requirements of device manufacturers and to assist the constraints of labeling in regulated environments. It provides additional layers of control, allowing businesses to more efficiently handle regulatory obligations like as UDI, EU MDR, and 21 CRF Part 11 throughout their worldwide operation.

Labeling applications for Medical Device

  • Design all-size Labels
  • FDA 21 CFR Part 11 Labels
  • And many more….
  • UDI Compliant Labels
  • GS1 barcode Labels
  • Clinical Trial Labels
  • HIBCC labels

How we can Help Medical Device Manufacturers


LabelingOnUs specializes in on-demand pre-configured solutions that provide you complete control over your label designs while decreasing lead times, inventories, and the expenses involved with installing a certified labeling environment.


Labeling Process

We assist businesses in managing labeling, which includes the design, approval, and validation of labels, testing and QA through validation, development, and production.


Configure Labeling

Configured on cloud or on premise and integrating with any data sources (ERP, SAP), the solution provides customizable workflow framework and eSignature abilities to enable visibility, complete audit tracking, and comprehensive control over label management.


Comply to Regulations

To streamline the label creation process and ensure compliance with industry rules, the software includes GS1-ready label templates as well as a full range of stock symbols.


  • control and consistency(medical devices)
    Control and ConsistencyLayering capabilities for label design allow distinct organizations or departments to own and govern a section of a label's real estate, allowing appropriate stakeholders to examine and approve layers.
  • multilabel layout capabilities
    Multi-Label Layout CapabilitiesEnsure printing versatility and efficiency by including labels with varying content and sizes in a single design that can be printed all at once.
  • audit capabilities
    Audit CapabilitiesThe ability to audit and manage sessions provides insight into user access and system modifications, which aids in compliance in validated environments.
  • real time analysis with reporting
    Real-time analysis with ReportingPre-defined reports provide real-time insight into the state and health of labeling activity throughout the enterprise.


  • AccuracyReduce human error by collecting data electronically
  • DesignMulti-label layouts flexibility and efficiency when printing
  • Role-based controlWith appropriate access to labeling content, gain more control on process
  • Efficiency Automating your process and eliminating paperwork
  • Cost savingWork seamlessly with zero downtime and reduced real-time errors
  • Fast return on investmentAutomated processes, manage recalls better and increase the overall efficiency

This Might Interest You


Our Solution Directory


LabelingOnUs specializes in offering Labeling Solutions that support your company objectives across the whole business process, from procurement through inventory management, warehousing and logistics, and customer experience. WE assist you in developing a unified Medical Device Labeling that smoothly integrates the online and offline environments.

What our customers say


Customers using our solutions


Over 100+ clients trust LabelingOnUs

Simple and Sophisticated Solution for most complex Medical Device labeling.

We’re here to help and answer any question you might have implementing a necessary UDI device identifier for medical devices and integrating with external data sources.