Certifications

Quality assurance (ISO13485)

METROVISION's products are manufactured under the most stringent quality control conditions. The quality assurance system of METROVISION complies to norms ISO13485-2016 and is submitted to a periodical inspection by a notified body.

Europe (EC certificate)

METROVISION's Vision Monitor systems are class IIa products. They fulfill the EU medical device regulation MDR(EU) 2017/745, Annex IX, Chapters I and III

USA

METROVISION is a FDA-registered medical device manufacturer. The MonCvONE, MonPackONE and MonCv3 devices are FDA cleared.