Medical Device Qualified Supplier Directory


Unique Device Identification (UDI) Requirements, Deadlines, Secure Labeling

The implementation of the UDI Directive is mandated for medical device manufacturers. This is not only true for companies that sell their products on the American market, since UDI is also being implemented in the EU and other countries. Medical products must be clearly identified to ensure safe traceability and patient safety. In addition to the marking of packaging and labels, this also applies to the direct marking of high risk products such as implants and instruments. Manufacturers must maintain deadlines and requirements to implement marking systems to apply marking in accordance with UDI requirements and medical standards. In order to implement the demanding labeling, serialization and marking requirements, appropriate technologies are required that allow the codes to be applied and checked with high resolution, permanence with exceptional quality and, if necessary, even in the smallest of spaces.

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FOBA Laser Marking + Engraving (ALLTEC GmbH)
E: [email protected]
T: (630) 694-3243
F: (978) 263-1903

1500 Mittel Blvd., Wood Dale, IL, 60191-1072, United States
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