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 […]
Switzerland considered a foreign country in the marketing of medical products.
https://www.devicesistemas.com/wp-content/uploads/2021/07/certificacion-ce-en-suiza-device-sistemas.jpg Switzerland must be considered a foreign country regarding the CE marketing of medical products. Switzerland must be considered a foreign country in the marketing of Medical Products. The European Commission published on May 26, 2021, a note addressed to economic operators related to the situation of the EU-Switzerland Mutual Recognition Agreement for medical products. […]