Originally signed into law in 2011 the Food Safety Modernization Act (FSMA) aims at protecting consumers through more in depth preventative action. FSMA provides the FDA broad new powers to prevent food safety problems, detect and respond to food safety issues and improve the safety of imported foods. FSMA intends this preventative action before issues arise […]
Implementing a mobile supply chain application into your companies environment can be viewed as a daunting and intimidating process. Pragmatyxs has developed a strategic relationship with DSI Global to utilize their solution accelerators with Pragmatyxs’ development experience to reduce this intimidation factor. Pragmatyxs; utilizing the solution accelerators from DSI Global can build an […]
With the second phase of UDI compliance dates coming in less than a year ( September 2015) for medical devices to require UDI labeling; it is imperative that organizations continue to advance their preparations to begin implementation of these labeling requirements and that preparation begins with populating the UDI database known as GUDID(Global Unique Device Identification […]
We have recently discussed the standards and regulations regarding the upcoming UDI ruling and how proper implementation is key. The FDA, who oversees that these standards are met, appropriately shared some insight on the ruling and a test-case example on why it is such an important decision for the health care system. Please read the […]
A great article from Med Device Online regarding the recent and upcoming changes to UDI compliance. These new regulations coming into affect will ensure proper information and identification is attainable to the consumer for proper use and understanding of the product. To view the full article click the link below: http://bit.ly/1DwOK0S
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 […]