Production and quality

Our products meet the highest quality standards, which is confirmed by numerous certificates and rigorous inspections. We care about safety, precision and reliability in every detail.

Quality Management System

ISO 13485:2016

METRUM CRYOFLEX has implemented and maintains a Quality Management System in accordance with the requirements of ISO 13485:2016, under the supervision of TUV NORD Polska.

CE

Medical devices manufactured by METRUM CRYOFLEX are CE marked confirming the compliance of the products with the requirements of Directive (EU) 93/42/EEC (MDD), Article 120 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2023/607 regarding medical devices. This compliance is confirmed by appropriate certificates and documents issued by TUV NORD Polska (NB no. 2274).

Medical Device Registration

Medical devices manufactured by METRUM CRYOFLEX are registered with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.