For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...