REGULATORY COMPLIANCE

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Description

Unique Device Identification (UDI) Labeling

The Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI). TEKLYNX labeling software helps businesses comply with 21 CFR Part 11, and is capable of printing HIBC and GS1 barcodes required to generate labels for UDI compliance, with support for thermal and thermal transfer printers.

Easily create and print UDI-compliant labels

·         CODESOFT for UDI label creation
    • Health Industry Barcode (HIBC) and GS1 Databar barcode creation
    • Easy-to-use wizards
    • Create user rights and enable label security controls
·         TEKLYNX CENTRAL CFR for Label Management
    • Pull label elements from a centralized database for UDI-compliant labels
    • Automate labeling process with central management to ensure process enforcement and additional control

About UDI

Many organizations within the healthcare industry face challenges ensuring their barcode labeling systems are compliant with various regulations.

 

The Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI), which is comprised of a unique numeric or alphanumeric code that is used to mark and identify medical devices within the supply chain.

 

As a result, all implantable, life-supporting/life-sustaining medical devices must bear a UDI label. Implementing UDI promises to reduce medical errors, simplify integration of data systems, and provide more rapid solutions to problems.

 

Full compliance with UDI includes three components:

 

  • Including the UDI in all applicable systems and procedures, including quality systems, medical device reporting, and corrections & removals
  • Accurate labeling of devices  and packaging including all specified information
  • Loading the Device Identifier (DI), along with all associated information, into the Global Unique Device Identification Database (GUDID)

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