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 […]