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Globally managing print operations with PXSmartLabel

Managing label and barcode print operations can be a heavy task for any administrator, especially when it comes to controlling operations across the globe. Ensuring that the correct label and the quantities printed are important for supply chain movement and accuracy. A disciplined approach to global label printing that is extended to all of the […]


FDA Ruling to take effect on 10/15/2015

The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA  with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail. […]


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 […]


Feedback from UDI’s first roll out

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

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 […]


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 […]


Avoiding counterfeit parts in electronic manufacturing

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

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 […]