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Software as a Service (SaaS)

Pragmatyxs is proactively looking to find solutions that will simplify your companies labeling needs. As product labeling continues to evolve we at Pragmatyxs believe Software as a Service (SaaS) is the latest and greatest solution to help your company be more cost effective, efficient and supportable. Below you will find the advantages to SaaS in […]


Why UDI & MDR?

In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important….   These compliance regulations provide for more accurate reporting, content review and the ability to report on device […]


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 […]


FDA Extends Mandates for Certain Class II Devices

The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]


In the News: Oracle Security Cloud Services Expanding

Oracle’s Security Operations Center (SOC) launched 6 months ago and has already surpassed 1 million users.  Pragmatyxs has placed a priority on Cloud services to extend and enhance our solutions and have been beyond satisfied with Oracle’s products, business plan and look forward to continue working with them in the future.  To read the full […]