When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]
The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]
Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk. As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.) Signed by […]
Consumers today are more educated on the products they purchase and are very conscious of what is deemed “healthy.” We have recently seen waves of food manufacturers facing lawsuits over false advertising, especially focused around foods labeled “healthy” and “natural.” Ryan Fournier, an international trade associate for law firm Armstrong Teasdale lists items manufacturers must […]
The FDA has released a safety communication for patients with a St. Jude Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device due to batteries failing earlier than expected. These ICD and CRT-D devices are critical to the survival of patients and there have been 2 reported deaths currently due to battery failure. […]
Paul Van Hout, Pragmatyxs CEO at Oracle Open World discussing the benefits of Oracle Cloud and how those benefits are utilized by Pragmatyxs. https://youtu.be/G8vt-jcbFVc
We are nearing almost 3 years of the original publication of the UDI final ruling. What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging. Class III regulations due Sept. 24th: UDI required devices […]