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In the News: Upcoming revision to ISO 13485

  Due to the overwhelming demand for updates to ISO 13485 which regulates medical device compliance; we expect to see some important changes by quarter 1 of 2016. The biggest revision expected is the compliance with international regulations; ensuring consumers that these devices have been tested and meet all safety requirements across the globe is […]

Traceability and its role in product recall

  Today’s consumer has become more informed and enlightened regarding the products they purchase, where they come from, what they are made of, and, most importantly, if they are safe. Product recalls when not handled properly can erode customer trust and result in costly litigation, a tarnished reputation and ultimately lost revenue. Traceability plays two very […]

UDI Compliancy for Medical Devices coming to affect

The FDA’s ruling for medical devices to carry a UDI (Unique Device Identification) will go into effect on September 24th. This will allow easy and definitive attributes of a medical device reducing errors in misidentification or improper use. Making these necessary can be a costly task for companies who aren’t prepared. That is where Pragmatyxs […]

In the News: ConAgra could face charges stemming from 2007 recall

    ConAgra foods is facing possible misdemeanor charges dating back to a recall on Peter Pan Peanut Butter from 2007 that sickened over 400 people due to salmonella.  The U.S. Department of Justice reached out to consumers in August informing them of the possible cause to their illness. Product traceability plays a huge factor […]

Tips & Tricks: Inconsistent Verifier Results

We are excited to introduce a new segment in our blog : Tips & Tricks!  The technology industry can be complicated and hopefully we can share some insight to make your life a little easier. Our first Tips & Tricks segment comes from a case study done by; read the full article below and […]

In the news… openFDA Project introduces MAUDE

The openFDA project is a database that allows researchers and developers access to countless reports on food, drugs and now medical devices. openFDA has now added MAUDE (Manufacturer and User Facility Device Experience); a database with reports on devices such as prosthetics, heart valves and robotics dating back to the early 1990’s. To view the […]

Around the clock support that can handle your end-to-end solutions

  Time and money are two of the most valuable assets in any business.  Both of these can be wasted trying to solve incidents within your supply chain; whether its contacting multiple vendors, contacting support after hours, dealing with call centers.  The list can go on; but there is a simple solution… Pragmatyxs Support. Pragmatyxs […]

In the news…. New era for Gluten Free

A new era has begun for Gluten Free labeling standards; the FDA ruled a year ago that foods bearing the “gluten free” label would be held to certain regulatory standards and those rulings are now in effect. Any food labelled “gluten free” must contain less than 20 milligrams of the protein. Consumers can now confidently […]

Keeping Up With Compliance Labeling

Implementation of and management of product label standards is at the forefront of any business that deals with consumer goods. With label compliance evolving rapidly your business can either thrive or hit bumps if you are not up to standards. Pragmatyxs’ PXSmartDesign service can offer your company the benefit of our almost 20 years in the label design industry.  Teamed […]

Improve Supply Chain Management with PX Smart Solutions

To be able to adapt and compete in today’s ever evolving global market having an efficient supply chain management system is critical for success. PXSmartSolutions provides technical consulting and project management services for any compliance labeling, material tracking or other system integration need. Pragmatyxs consultants have over 100 years combined experience in the integration field […]