ISO 14971:2019–Risk Management To Medical Devices
Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the…
ANSI/AAMI SW96:2023—Medical Device Security
The steps that involve manufacturing, regulation, planning, assessment, acquisition, and management of medical devices are complex but essential to guarantee their quality, safety, and compatibility…