Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Back when the pandemic first hit, many students received tablets or laptops from their schools. Schools also wanted to know what students were doing on those devices, so demand for AI-powered software ...

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 ...

As the popularity and value of cryptocurrency rises, device designers are drawing on research and testing to optimally ...

PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...