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UDI

Unique Device Identification (UDI) solutions for medical device manufacturers. Expert guidance on UDI compliance and implementation strategies.

September 24 has become a date that inspires anxiety among medical device manufacturers. September 24, 2014 was the UDI (unique device identifier) compliance deadline for…

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The current regulations are the result of a final rule released in September of 2013 by the FDA, which stipulated that most medical devices carry…

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All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception…

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