Quality

Quality Management Systems

The basis of our company’s operations is a certified quality system that meets the requirements of the international standards ISO 9001:2015 and ISO 13485:2016. 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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