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Upcoming UDI Class III and Class II Compliance Dates

We are nearing almost 3 years of the original publication of the UDI final ruling.  What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging. Class III regulations due Sept. 24th: UDI required devices […]


Improving UDI Barcode Quality and Verification

One of the largest labeling regulations in recent history; UDI (Unique Device Identifier) labeling has been at the forefront of any medical companies agenda to not only implement new information but to also properly display this critical information in a proper fashion. Barcode-test.com provided simple yet resourceful list of common issues that they have seen […]


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 […]