Quality

Quality Management Systems

the ISO 9001 – certification formed the cornerstone of our quality policy development during the years 2002-2026. The ISO 9001 certification was discontinued in 2026, as the ISO 13485 certification covers the quality management requirements essential to our operations from a health technology perspective.

The basis of our company’s current operations is a certified quality system that meets the requirements of the international standard ISO 13485. The certified quality system covers all aspects of our operations from product development to manufacturing and sales.

In addition, Reagena has an IVDR certificate issued by the Notified Body Eurofins (NB number 0537). This certificate confirms that Reagena meets the requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

All Reagena’s IVD devices are compliant with the IVDR, or qualify as legacy devices under its transitional provisions.

Our products intended for pharmaceutical use are manufactured in accordance with the requirements of the European Pharmacopoeia (Ph. Eur.).

Quality certificates

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