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Benefits of a Standardized Labeling Solution

With manufacturing plant locations and distribution facilities operating globally, companies are seeing the benefits of developing a standardized global labeling approach. Pragmatyxs has been engaged in developing solutions for global label operations for many years. We have consulted with many organizations that have multiple plant locations in migrating from their own custom legacy labeling solutions […]


MDR/IVDR

Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]


Growth of Anti-Counterfeiting packaging

Counterfeit products are a growing problem for businesses all over the world, resulting in huge economic losses and even possible harm to consumers. The effects of counterfeiting are felt in a variety of industries like pharmaceutical, food, beauty, technology, among others.         According to the Anti-Counterfeiting Packaging Market report from Markets and Markets Research: […]


EU MDR Compliance Labeling

The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]


How do I manage all the projects that I have and still get compliant on UDI?

UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you  have additional requirements to maintain these […]


FDA UDI Class I

Several dates for UDI compliance have been postponed: •         Class I and unclassified devices – 24th of September, 2020 •         Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]


Our deepest condolences and support to Puerto Rico

The Pragmatyxs family would like to send our sincerest condolences to Puerto Rico during these tough times and offer our hand in assisting in any way possible.  Please know you are not in this fight alone.   If your business or personal matters have been affected by these natural disasters please reach out to Pragmatyxs […]


510(K) Medical Device Exemptions

FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st […]


Oracle OpenWorld- How a small business sells world class services to the fortune 500

Oracle OpenWorld- How a small business sells world class services to the fortune 500 Pragmatyxs might be a small company, but they have some very big clients. The 15-person firm works with Fortune 500 companies to bridge the communications gap between supply chain or ERP systems and barcode and product labels. “The labels that you […]


UDI Exceptions on Single Use Devices

Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]