As with risk management, verification and validation are essential topics that must be investigated separately in order to make sure they are fully understood. Yet these are integral steps in the...
Design outputs are the result of each design phase and of the entire design effort. A completed and finished design will culminate in the device itself, its labeling and packaging, and the device...
While the word “design” often suggests a creative, trial-and-error process, design, as it applies to medical devices, must be a well-controlled, thoroughly documented process. Design controls are...
Welcome back to our series on static & dynamic analysis and unit testing. In this post, we discuss dynamic analysis, which is when you actually execute the program on a real or virtual machine to...
