[Regulatory requirements for software medical devices: Comparison between Europe, the United States, and Algeria].

Abstract

Software Medical Device (SWMD) are essential digital tools used in the healthcare sector for various medical applications. Like any medical device, MDS are subject to strict and rigorous regulations that vary from country to country, aiming to ensure their quality, safety, and effectiveness. This study examines the regulation of SWMD and compares the definitions, classifications, and approval processes in Algeria, Europe, and the United States, pointing out the similarities and differences among