Governance

CERTIFICATIONS

• Technogenetics is certified according to ISO 9001/2015 and ISO 13485/2016
• Technogenetics manufactures and markets products in accordance with EU Regulation 2017/746 -IVDR

The CE marking attests to the performance of and compliance with a complex series of procedures, to which in vitro medical-diagnostic devices must strictly conform. These procedures are prerequisites for the obtaining of Marketing Authorization and for use of such devices “for the diagnosis, prevention, monitoring treatment or alleviation of disease”.