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Pragmatyxs Expands Partnership with NiceLabel

  The Pragmatyxs team has deep experience in the barcode systems and product labeling. In our over 25 years in the business we have consistently maintained an emphasis on enterprise-level requirements and systems integration.  Because of this focus we are excited to be expanding our partnership with NiceLabel. NiceLabel’s next generation labeling software is specifically […]


EU Falsified Medicines Directive: Barcodes

The EU Falsified Medicines Directive (FMD), which has been introduced to reduce the risk of counterfeit medicines in the supply chain, comes into force on February 9th, 2019. Requiring all 150,000 community pharmacies throughout the EU to implement the FMD. From this date, all prescription medicine packs must have a unique code which will be […]


Labeling Regulations by Industry

Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional  demands for compliance labeling. Chemicals: Global harmonized […]


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 […]


COMPLIANCE LABELING- BENEFITS OF AN EXPERIENCED INTEGRATOR.

When it comes to making labeling work across global supply chains, many organizations have tried to meet their evolving needs through a variety of homegrown custom solutions. Such solutions may provide steps in the right direction, but they don’t get the job done adequately. These solutions can work to solve immediate challenges but are not […]


Food & Beverage Compliance requirements

Here are some examples of the requirements for labeling in Food & Beverage Examples: The FDA’s Food Safety and Modernization Act (FSMA), aimed at preventing food contamination across every step of the supply chain, including use of imports and exports across international boundaries. FSMA also gives the FDA authority to order a mandatory recall of […]


UDI Labeling in 2018

With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US. The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class […]


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 […]