Posts by Robert Keur

As my colleague, Virginia Anastassova, noted in her recent blog, Unique Device Identifiers (UDIs) have been one of the hot topics in the Medical Device world in the last few years.  It seems like a good time for a quick refresher on medical device labeling in general.  I’ve also included my list of Do’s and […]

The phrase “good enough” may have a negative connotation, but it is a critical concept in the development of a medical device. As applied to the device performance levels, knowing what is required to achieve the device’s effectiveness goals is, surprisingly, an often overlooked aspect of the design process. Too often these requirements are assumed, […]

My first experience with a quality manual was not a good one. The manual for an ISO 9000 certified company consisted of the standard with the words “the company will” inserted before each clause. A slight exaggeration, but you get the point. After reading the manual one had very little idea of how the company intended […]