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 […]
Mobile devices play a huge role in everyday tasks from communication, activity monitoring and endless other abilities and now DSI Global brings supply chain management into the palm of your hands. Centering your supply chain around the customer not only meets their demands and expectations but allows you to operate a transparent, innovative and efficient […]
Globally Harmonized System of Classification and Labelling of Chemicals or GHS is a landmark regulatory standard ensuring global recognition of hazardous materials and how they are handled. Many countries have began the process of training their workers as well as implementing the proper labeling of goods. GHS regulatory standards have begun with educating anyone […]
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
A very informative post from barcode-test.com on scan rate and the variables that affect successful results. Scan rate has a direct influence on quality and time management. To view the full article click the link below. http://bit.ly/1vKRmog
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 […]