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Quality Assurance with Traceability

Demand for safe packaging to combat illicit drug market rackets spread across the globe is increasing. The present market is plagued by forged pharmaceutical formulas. The soaring market size of counterfeit drugs is creating a parallel economy in the global market. The emerging threat has a rippling effect on all the stakeholders as well as […]


Preparing to Meet UDI Compliance Dates

The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]


FDA to kickoff Drug Supply Chain Security Act meeting this month

Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk.  As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.) Signed by […]


In The News: Premature Battery Depletion of ICD and CRT-D Devices

The FDA has released a safety communication for patients with a St. Jude Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device due to batteries failing earlier than expected. These ICD and CRT-D devices are critical to the survival of patients and there have been 2 reported deaths currently due to battery failure.  […]


Latest features in the always evolving PXSmartLabel

Pragmatyxs Smart Label (PXSL) is our answer to simplifying the label printing process; while it is a very intuitive, easy to use tool to the operator it is a product that allows so much more than meets the eye.  Pragmatyxs is constantly reviewing and implementing new features that we feel will improve our customers everyday […]


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 […]


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 […]