Embedded device cybersecurity is relatively new compared to our friends with the “big iron” in Managed Information Systems (MIS), so while there are many differences between the two domains, there...
Welcome to the final installment of our breakdown of the new FDA cybersecurity standards In this post, we’ll look at required documentation manufacturers need to include in their premarket...
Labeling is any written text that identifies any part of a medical device. This includes a label directly on the device, user manuals, instructions for use (IFU), labels present on the outside of...
Welcome back to our continued breakdown of the new FDA Cybersecurity guidance. In this post, we will conclude our analysis of the “Trustworthy Devices” section of the document.
