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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 […]


In the News: FDA final ruling published for Nutrition Facts

We have posted  previously on the potential changes on the Nutrition Facts label.  The Nutrition Facts label is one of the most commonly read and recognized labels in the U.S. While the overall design of the Nutrition Facts label will stay the same the content within the label will see some changes, here are some […]


Upgrading to BarTender 2016: Integration Builder

Earlier this year we announced the newest release of BarTender from Seagull Scientific (http://www.seagullscientific.com/) and covered the new Administration Console features.  Users familiar with BarTender are familiar with the Commander feature; in BarTender 2016 Commander is know known as Intergration Builder but there is more than just a name change involved. Through highly customizable, intuitive […]


Tips and Tricks: Benefits of using 2D Barcodes

Barcodes play a huge role in product labeling, reducing errors, expediting movement through the supply chain, inventory management and point of sale.  Barcodes are the lifeline for product labeling; they hold vital information content whether it be how the product is handled, how it is inventoried or where it needs to be shipped. Many organizations […]


Depuy Synthes reaches 100% compliance on Class II UDI Regulations

Depuy Synthes (www.depuysynthes.com) one of the largest manufacturers of orthopaedic and neurosurgery products has reached 100% compliance for UDI Class II. Pragmatyxs was retained as a strategic partner for DePuy Synthes to achieve this milestone. Pragmatyxs assisted in building the database where all product codes related to UDI are integrated into Depuy Synths ERP system […]


Second UDI Compliance deadline due in September

In September of 2013 the Unique Device Identification (UDI)  Ruling was put into action responding to the demand for more clarity, understanding and an easier way to update medical devices.  Manufacturer’s have been implementing this ruling into their processes and come September 24, 2015 the second deadline will be put into action.  Non-class III implantable, […]


Ruling to come soon on updating generic drug labels

Drug Manufacturers  need to provide customers with  vital information on their product labels such as product ingredients and the possible side effects of the product. This information has become a top priority with any drug manufacturer.  Unfortunately we have seen many incidents where products did not contain the proper warnings and the outcomes can be […]


In the News: FDA announces UDI marking clarification

There is a recent release on a UDI ruling regarding the direct marking of the medical device.  Device Manufacturers have been implementing data requirements anticipating this ruling and now have a clear understanding of possibly the most important piece; the physical marking on the medical device. One of the leading factors in the marking process […]


In the News:Tennessee OR tracks consumable supplies with RFID technology

The future of RFID tagging is looking more promising than ever.  The  RFID Journal expects the industry to reach over $5.4 Billion by 2020. A unique story we discovered on RFID Journal’s site was one that came from the operating rooms at the University of Tennessee Medical Center; they had implemented the tracking of consumable […]


Preparing for possible Nutrition Label changes

It has been over 20 years since the Nutrition Labeling and Education Act was passed requiring that all foods contain facts on the product labeling to promote education and health awareness when choosing products. After numerous petitions for an updated Nutrition Facts label, a proposal was made last spring and is in the final stages […]