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Benefits of a UDI System

When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]


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 […]


Tips and Tricks: Ensuring clean label accuracy in food manufacturing

Consumers today are more educated on the products they purchase and are very conscious of what is deemed “healthy.”  We have recently seen waves of food manufacturers facing lawsuits over false advertising, especially focused around foods labeled “healthy” and “natural.” Ryan Fournier, an international trade associate for law firm Armstrong Teasdale lists items manufacturers must […]


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 […]


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 […]


Staying ahead of the requirements curve with PXSL

Pragmatyxs SmartLabel (PXSL) wasn’t created for just improving print operators user experience on the manufacturing and labeling line.  It was also created as a tool that can offer proper validation, record history and security. Pragmatyxs is constantly evolving PXSL to not only meet customer requirements but also to improve processes that organizations haven’t even thought […]


In the News: Senate Passes G.M.O Labeling Rule

The G.M.O.(Genetically Modified Organism) labeling rule has been a widely discussed topic in the food labeling industry.  While some wanted full transparency on whether products contained G.M.O’s other fought the regulation in its entirety claiming increased production and labeling costs.  Congress has agreed to a bipartisan agreement on the matter allowing companies to disclose whether […]