Comply with critical healthcare labeling regulations with TEKLYNX barcode label design software solutions.

The FDA has issued a final rule that requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI). September 24, 2016 marks the compliance date for Class III devices required to be labeled with a UDI to bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

Read the case study on how TEKLYNX CENTRAL CFR helped medical device packaging and outsourcing solutions provider, Quality Tech Services (QTS), increase efficiency by 40% and become UDI compliant.

Find out how TEKLYNX fits with your industry:

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TEKLYNX CENTRAL CFR has been leveraged from a solid application platform and wrapped with functionality to provide seamless integration into the entire regulated enterprise. Pharmaceutical companies, high-volume laboratories and other organizations that require a robust Quality Management System will find that Validation of this new product in their end-user environment is extremely straight forward.

- Tony Raymond,Consultant/President of New Harbor SQA


  • UDI labeling software
  • HIBC and GS1 Databar barcode creation
  • Lab sample tracking
  • Employee ID badges
  • File management
  • Patient wristbands
  • Medication labeling