We are excited to share that GenDx received the new certification for our MDSAP-compliant quality system by our notified body TÜV SÜD. The scope of the certification entails the design, development, manufacture and distribution of In Vitro Diagnostic Medical Devices including software. Besides the regulatory requirements of Canada, our MDSAP quality system now also covers the Brazilian regulations.
The MDSAP certificate is a prerequisite to register our products as in-vitro diagnostic (IVD) device in Brazil.
