Before assigning UDIs to products, there are a number of questions a manufacturer needs to answer about their products. “What is the base unit of my product?” “What are the packaging configurations?” “What products are currently in distribution?” In addition to these questions, one that I have been asked recently has to do with PACKAGING…
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UDI Talk: More Than Just a Project
In times of war, it is a common misconception of the general public that after one or two battles, the war will be over, the troops will return home, and peace will be restored. This is the power of naiveté coupled with hope and a great pair of blinders. This same coupling of naiveté and…
UDI Talk: Accessory vs Spare Part
Class II medical device manufacturers are plunging into the depths of the UDI Regulation and finding that some days more questions are raised than are answered. One question we’ve had at Qualitas Professional Services is if a UDI needs to be applied to a replacement part for a device. To answer this, we must first determine if the part…
UDI Talk: What Comes First – Labeling or GUDID?
I recently had a medical device company contact me for help establishing a labeling process at their facility. During the conversation I asked them what they were doing to prepare for the GUDID deadline on 24 September 2016, to which they responded “Let’s tackle labeling first.” The UDI regulation can be split into two major…