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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.

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Industry News

Embracing UDI Labeling and a Validated Solution
In contrast to last year’s UDI event, attendees at the recent UDI Conference in Baltimore seemed more positive and accepting of the regulation. Not that anyone has ever questioned the intent or goal...

Craig Hodgson on June 22, 2017

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Get UDI Labeling on Fast Track to Validation, Optimization
Billed as “the ONLY event dedicated to guidance and training for those impacted by the UDI Regulation,” the annual UDI Conference takes place next week on June 6-7 at the Hilton Baltimore in...

Craig Hodgson on June 2, 2017

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Resources For This Industry

On-Demand Webinar with GS1: Make UDI Labeling a Program, Not a Project

GS1 UDI webinar webpage.jpg

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.


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

Medical Device Labeling Q&A

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.