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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 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 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 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.

Customer References verified by TechValidate.

Resources For This Industry

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.
Medical Device Labeling Q&A
Q&A Report: 6 Critical Questions (and Answers) on Medical Device Labeling
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.

On-Demand Webinar with USDM Life Sciences: Taking the Pulse of UDI Compliance
Featuring Jay Crowley from USDM Life Sciences, this webinar reviews results from a recent UDI survey of medical device professionals and provides insight into the keys to achieving sustained 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.

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Industry News

Top 3 challenges with UDI Compliance for Medical Devices
This month, Sept. 24th to be exact, is the FDA deadline for labelers of soft contact lenses to comply with the Unique Device Identification (UDI) system for class II and III soft contact lens...

Craig Hodgson on September 11, 2017

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Medical Device Labeling for Highly Regulated, Competitive Marketplace
Labeling can be challenging and today’s medical device manufacturers are faced with a range of evolving requirements and regulations such as UDI, that complicate the process. But labeling can make a...

Maureen Perroni on August 3, 2017

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