Institut Virion\Serion GmbH
Quality is our standard
Keeping our quality standards high is of the greatest interest to us. For products of risk class C the certification according to REGULATION (EU) 2017/746 (IVDR) is already realized. General transitional provisions are defined by article 110 of the IVDR. All diagnostic medical devices are CE marked. Moreover, the quality management system is certified according to DIN EN ISO 13485.
The following certificates are available for download here: