Medical Device Labeling

Medical device companies have the added pressure of complying with regulatory requirements like the FDA's Unique Device Identification (UDI) system, while keeping operations running smoothly. That's why more and more manufacturers are reevaluating their labeling process to achieve sustained compliance and keep up with growing market demands.

The right Enterprise Labeling solution lets companies throughout the medical device supply chain turn labeling into a high-value, strategic element of the overall manufacturing and distribution process. By tightly integrating medical device labeling with business processes you already use, you can:

  • Automate and centralize labeling to improve accuracy and eliminate complex, error-prone data replication
  • Respect and leverage “validated sources of record” to comply with regulatory, customer and CMO requirements
  • Easily build and securely share templates that comply with UDI, 21 CFR Part 11 ERES and other regulations  
  • Reduce label template maintenance with an integrated and automated solution
  • Quickly configure and update medical device labels to meet evolving needs, expand into new markets
  • Save time and reduce cost of implementing a validated enterprise labeling solution
  • Extend labeling to distributors, suppliers, 3PLs to eliminate relabeling—save millions in inventory costs
  • Leverage standardized enterprise-wide labeling and GS1 standards to improve tracking and tracing of  medical devices

No wonder many of the leading medical device companies rely on Loftware Enterprise Labeling Solutions. By driving labeling straight from ERP, MES, PLM, Compliance and other enterprise systems, those “sources of record,” the label is always accurate. You can comply with customer and regulatory demands to keep product moving—even across international boundaries.

Learn more and download our brochure Enterprise Labeling for the Medical Device Industry.

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Resources For This Industry

White Paper w/USDM: Navigating Global UDI Regs
White Paper with USDM: Navigating Global UDI Requirements
The global roll-out of UDI regulations (like the EU's MDR) requires companies to rethink their approach to label management. Check out this new paper to learn how Enterprise Labeling helps you sustain compliance while improving overall efficiency.
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Regulatory Labeling Guide: 6 Best Practices
Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance
While different industries have different regulations, they all have common labeling challenges. Check out these best practices that will help you meet compliance while driving supply chain excellence.
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Webinar: 5 Things You Need to Know About Global Med Device Labeling
On-Demand Webinar: 5 Things You Need to Know About Global Med Device Labeling
Check out this webinar as USDM’s Jay Crowley discusses recent European Medical Device Regulations (MDR), as well as strict labeling demands from Russia, and how you can help ensure compliance.
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GS1 UDI webinar webpage
On-Demand Webinar with GS1: Make UDI Labeling a Program, Not a Project
Watch this timely and informative webinar as GS1's Greg Bylo provides insight into the standards and technology to help you sustain UDI compliance while improving supply chain performance.
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