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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 […]

Feedback from UDI’s first roll out

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The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us  and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]

FDA looking to new sugar labeling regulations

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The FDA is continually looking to improve not only the safety of food and drug manufacturing but also to provide a clear understanding of these products to consumers.  The FDA is proposing manufacturers implement labeling changes that identify natural sugars and those added. While including the amount of natural and artificial sugars in a product […]

Reducing counterfeit drugs in your supply chain with DSI and Pragmatyxs

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Counterfeit drugs have become a growing issue in the Medical Manufacturing industry and as technology advances we are seeing more and more occurrences.  We have addressed in previous posts the major risks in counterfeit products and how they can have a severe impact on the consumer. We rely on the integrity of the drug supply […]

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 […]

Avoiding counterfeit parts in electronic manufacturing

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When we refer to the word counterfeit in the regulatory industry we commonly associate it with Medical Device and Pharmaceutical manufacturing that can cause adverse affects to human safety. The same can be said in the electronic industry; for example; electronics drive the Aerospace and Defense industries as well as our everyday electronic tools that […]

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 […]