Barcode Verification for UDI and Global Medical Device Labeling

The FDA’s Unique Device Identification (UDI) regulation continues to be a critical aspect of the transition that the medical device community is making in its digital global future. Print quality and content have minimum quality standards set by regulators to ensure the healthcare community goals of patient safety and efficiency are met. Barcode verification plays an important role within this effort as the FDA’s UDI regulation requires medical device labels to have a barcode with a grade C or better to be UDI compliant.

“We’re excited to partner with leading barcode verification provider AIS to educate medical device manufacturers about the importance of barcode verification,” states TEKLYNX Enterprise Product Manager Nick Recht. “It’s another way we help AIDC end users leverage technologies and technology partners to make their companies work better.”

During the webinar, TEKLYNX and AIS will discuss the FDA’s UDI regulation and the important role barcode verification plays in meeting these requirements. Webinar attendees will also learn: 

  • Why barcode verification is critical for medical device labeling
  • Why barcode verification is necessary to comply with FDA and EU regulations
  • How barcode verification plays an important role in meeting industry-specific regulations
  • What the components of designing and printing a UDI compliant label include

Nolan will also provide its first-ever live demonstration of SCANALYST 3 GUDID, its barcode verification and compliance solution for UDI labeling. This comprehensive system inspects against print quality minimums, normally referred to as barcode verification, as well as checks barcode data formatting and synchronization with the FDA’s Global Unique Device Identification Database (GUDID). Nolan says, “This thorough inspection approach will play an important role in UDI implementations for manufacturers, distributors and providers as they prepare their organizations for the future.”

The January 25th Barcode Verification for UDI and Global Medical Device Labeling webinar also features a live question and answer format so attendees can gather insights specific to their organizations needs. To register, visit To learn more about UDI labeling requirements including information on the upcoming September 24th, 2018 compliance deadline, download TEKLYNX’ free eBook: Are You Ready for UDI?

About TEKLYNX International 
TEKLYNX International is the world’s leading barcode and RFID labeling software developer and solutions provider. An industry innovator for over 30 years, TEKLYNX helps companies operate smoothly and efficiently by implementing labeling solutions that streamline operations while staying ahead of industry-specific compliance and emerging regulations. TEKLYNX is world-renowned for its customer service; offering flexible purchase options, unparalleled service and support, and a comprehensive product offering that grows with companies over time. With operations in the United States, Europe, Japan, Latin America, China and Singapore, more than 630,000 companies in over 120 countries look to TEKLYNX integrated software solutions for their standard of success. 

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