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ORTHOKEY products meet the applicable requirements of 93/42/EEC Directive and subsequent amendments and additions. Our manufacturing processes and quality system comply with UNI CEI EN ISO 13485:2016 in the field of design, manufacture, service of medical devices inherent to navigation system for computer assisted surgery and for detection of anthropometric and kinematic data.

 

Download our Certifications:

Download CertifcateBLU-IGS - CE Certificate

Download CertifcatePERSEUS - CE Certificate

Download CertifcateKiRA - CE Certificate

Download CertifcateUNI EN ISO 13485:2016 - ORTHOKEY