If your organization is looking to maximize and/or expand your BarTender capabilities, consolidate templates, increase printing efficiency or want a refresher course, Pragmatyxs Inc. has expert instructors and a variety of curriculum options to choose from. As a preferred Seagull Scientific partner, we have the experience and expertise to help your team become labeling experts. […]
This Zebra PAX4 End of Serviceis to inform the reader of this memo that service and support for all Zebra PAX4 models will be discontinued on November 15, 2018. After this date, service and support will no longer be available from Zebra. It is strongly suggested that Zebra PAX4 users migrate to the most recent […]
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 […]
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 […]
The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]
Paul Van Hout, Pragmatyxs CEO at Oracle Open World discussing the benefits of Oracle Cloud and how those benefits are utilized by Pragmatyxs.
Unique Device Identifier (UDI) The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. A UDI system has […]
In the news…… U.S. Approves a Label for Meat From Animals Fed a Diet Free of Gene-Modified Products NY TIMES The Agriculture Department has approved a label for meat and liquid egg products that includes a claim about the absence of genetically engineered products. It is the first time that the department, which regulates meat […]