Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regulatory submission—the device description. While this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews the role this section plays in a regulatory submission and common mistakes that occur are covered. Specifically, the following questions are addressed:Of all the potential topics we could be covering, why has device descriptions come up as one we should discuss?What support do you have to say device descriptions are one of the most poorly written sections of a pre-sub or final regulatory submission?What is the point of the device description in a regulatory submission? Why would it be so important to get it right?How can you verify your device description does its job? How do you know?How do you balance technical detail with simplicity in a device description, especia