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  • nicoleb replied to the topic Update to Classification System in the forum Introduction to Project Management 6 years, 4 months ago

    I believe the system is fine as is. During this weeks mini-sim i chose the bluetooth connected glucose meter and pump. Although there has not been a device like this on the market, you can think of this as a combination of two different devices, a glucose meter and insulin pump. Therefore, my initial instinct was to pick this as a class 2 device, however I was incorrect and learned that this would be a class 3 device. To my understanding of the mini-sim this would be because of the software that is involved in the bluetooth connected glucose meter and pump, and the possible issues that could arise because of this new software. Therefore, the classification of this device was a class 3. I believe rightfully so, because although there are similar devices on the market it is in the best interest of public health to test this device more thoroughly in order to prove utmost safety and efficacy.