Author Bio
While you wouldn’t guess it now based on my 20-mile round-trip commute, I haven’t always been an eager biker. I was lucky enough in my childhood to spend a lot of time on a bicycle, zooming up and down the hilly driveways of my neighborhood with my brother and sister. When high school began, however, […]
Every company that produces medical devices has to plan for that time when they must present compliance evidence to the FDA auditor. Often the most difficult and time-consuming aspect of this process is sorting through the available documentation produced by the design and development team, including outputs from multiple software tools. Even in that best-case […]