Is My Software a CDx or Not?
https://www.devicesistemas.com/wp-content/uploads/2024/10/IVDSW.png Software as an In Vitro Diagnostic Medical Device First, before determining whether our software is a CDx or not, we must adequately justify that our software is an In Vitro Diagnostic Medical Device. (according to IVDR). An In Vitro Medical Device Software (IVDSW) is one that meets the definition of an In Vitro Diagnostic […]
Is my software or application a medical device?
https://www.devicesistemas.com/wp-content/uploads/2023/11/app-sofware_producto_sanitario.jpg Determining which health “apps” and/or software are considered medical devices varies according to the laws of each country. Is my health-oriented software or application a medical device? There is no doubt that mobile phones and tablets with all their applications have represented technological advancement, and of course, these advancements have also affected the healthcare […]