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 […]
Medical Device Software MDSW. CE Marking Marketing Strategies
Medical Device Software MDSW are medical products that must have CE Marking to be marketed in the European Union. MDSWs that work together with a medical product or component of a medical product can use different marketing strategies to be sold in the European Union.