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Depuy Synthes reaches 100% compliance on Class II UDI Regulations

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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

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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

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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

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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

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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

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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 […]

How Pragmatyxs improved J Crew’s supplier printing

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Retailers rely heavily on manufacturing vendors to assist in supplying quality products to their supply chain operations in a timely manner.  Communication between hundreds or even thousands of vendors can be extremely overwhelming and details can be missed.  To operate efficiently it is vital to implement controlled shipping controls in your supply chain that are […]

In the News: Public access to Global UDI Database

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The UDI ruling has been hailed as a landmark decision in the medical supply industry as it allows for better education to doctors and to patients on the devices and products that are utilized as well as the ability to provide updates and recalls on products. The FDA has announced that public access is now […]

Potential changes to the GMO Labeling Act

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The food labeling industry has continued to discuss whether genetically modified goods should have labeling requirements.  A few states have had bills proposed but none so far have passed; while some manufacturers are marketing all natural products to drive sales others are arguing that there are no health concerns with genetically modified goods. The issue […]

Implementing proper barcoding for your UDI transition

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The UDI ruling and implementation process has been discussed in many forums. In our previous discussions we have covered certain dates and criteria that are required to meet the upcoming regulations but one thing that has not been discussed significantly is one of the most important pieces: the UDI bar code and the implementation process. […]