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 […]
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 […]
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 […]
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 […]
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 […]