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08/03

2016

The Impact of ISO 13485

The publication of the ISO 13485:2016 standard in March of this year realizes work that began in July 2014 with the rejection of the first Draft International Standard (DIS)

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01/28

2016

New Acronyms from the FDA: UDI and GUDID

On September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.

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