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 […]
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 […]
The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]
In September of 2013 the Unique Device Identification (UDI) Ruling was put into action responding to the demand for more clarity, understanding and an easier way to update medical devices. Manufacturer’s have been implementing this ruling into their processes and come September 24, 2015 the second deadline will be put into action. Non-class III implantable, […]