BSI-ISO IVDR 780538-R000

by Konstruct Digital | May 5, 2026

Microbix Biosystems holds EU Quality Management System Certificate No. IVDR 780538 R000, issued by BSI under the EU In Vitro Diagnostic Regulation (EU) 2017/746. Covering in vitro diagnostic controls for monitoring the detection of infectious agents, this certification confirms Microbix’s quality system meets European regulatory requirements for IVD devices and is valid through September 2029.

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