The UDI ruling has been hailed as a landmark decision in the medical supply industry as it allows for better education to doctors and to patients on the devices and products that are utilized as well as the ability to provide updates and recalls on products. The FDA has announced that public access is now […]
The food labeling industry has continued to discuss whether genetically modified goods should have labeling requirements. A few states have had bills proposed but none so far have passed; while some manufacturers are marketing all natural products to drive sales others are arguing that there are no health concerns with genetically modified goods. The issue […]
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 […]