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FDA Ruling to take effect on 10/15/2015

The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA  with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail. […]


Depuy Synthes reaches 100% compliance on Class II UDI Regulations

Depuy Synthes (www.depuysynthes.com) one of the largest manufacturers of orthopaedic and neurosurgery products has reached 100% compliance for UDI Class II. Pragmatyxs was retained as a strategic partner for DePuy Synthes to achieve this milestone. Pragmatyxs assisted in building the database where all product codes related to UDI are integrated into Depuy Synths ERP system […]


Feedback from UDI’s first roll out

The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us  and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]


In the News: Public access to Global UDI Database

The UDI ruling has been hailed as a landmark decision in the medical supply industry as it allows for better education to doctors and to patients on the devices and products that are utilized as well as the ability to provide updates and recalls on products. The FDA has announced that public access is now […]