The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European In-Vitro Diagnostic
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices Navigating the complex landscape of in-vitro diagnostic (IVD) medical device regulation, ISO 20916 emerges
In the continually evolving field of medical diagnostics, the introduction of ISO 20916:2019 has marked a significant milestone. Published in May 2019, this International Standard,