We're frequently asked whether Minitab has been validated by the U.S. Food and Drug Administration (FDA) for use in the pharmaceutical and medical device industries.
Minitab does extensive testing to validate our software internally, but Minitab’s statistical software is not—and cannot be—FDA-validated out-of-the-box.
It is a common misconception that software vendors can go through a certification process to achieve FDA software validation. It's simply not true.
Software vendors who claim their products are FDA-validated should be scrutinized. It is up to the software purchaser to...