ISO Certificates


EN ISO 13485:2016/ISO 13485:2016 certificate – Genome Diagnostics B.V.

The scope of the certification entails the design and development, manufacture and distribution of Nucleic Acid Based In Vitro Medical Devices (including software), contract laboratory services and the provision of training and support. This certification also includes the location(s) as identified on the addendum belonging to this certificate.

 

MDSAP certificate

The scope of the certification entails the design, development, manufacture and distribution of In Vitro Diagnostic Medical Devices (including software) for Canada.

Health Canada - Medical Device Licenses