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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

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.
On-Demand Webinar: Move Inventory Faster. It Starts with the Label.
On-Demand Webinar: Move Inventory Faster. It Starts with the Label.
Learn how innovations in Enterprise Labeling provide a new level of visibility into inbound shipments and supplier behavior—saving thousands, even millions of dollars in relabeling and inventory costs.

GS1 UDI webinar webpage
On-Demand Webinar with GS1: Make UDI Labeling a Program, Not a Project
Enter Description 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.
Medical Device Labeling Q&A
Q&A Report: 6 Critical Questions (and Answers) on Medical Device Labeling
Enter Description US and international UDI requirements. Supply chain complexity. Rising costs and effort to validate solutions. Get an expert's perspective on how you can tackle these labeling challenges and improve efficiency.

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Industry News

Webinar: 5 Things to Know About Global Med Device Labeling
Just when you thought you had a good grasp—or at least a reasonable understanding—of the FDA’s UDI system and its associated labeling requirements, along comes the EU’s Medical Device Regulations...

Laura Johnson on November 28, 2017

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Dealing with Labeling Regulations: UDI Dating [Video]
Welcome back to the Loftware blog. Today we'll continue discussing the many complex regulations manufacturers must follow when labeling sensitive products for use around the world.

Maureen Perroni on November 20, 2017

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