Bio-Rad gets EU QMS certificate for 40 QC products
May 2025—Bio-Rad Laboratories has received the EU quality management systems certificate under IVDR regulation (EU) 2017/746, enabling the CE-IVDR marking of 40 Exact Diagnostics infectious disease molecular quality controls. The controls are formulated with whole organisms in relevant matrices to simulate patient specimens. This design aims to ensure that the controls undergo the same workflow and process challenges as patient specimens during routine testing.
