ISO 13485:2016 certification

Biomech Innovations today announced that its quality management system (QMS) has been certified by Italcert as ISO 13485:2016 compliant. Italcert is a Milan based notified body with remarkable experience in orthopedics.

Compliant to European and US requirements its scope enables Biomech Innovations to execute on development, manufacturing and distribution activities necessary in order to bring safe and effective medical devices to the European market and later to the US and other international markets.

Stefano Brianza, Biomech Innovations’ CEO and founder, said: “The certification of the quality system is a fundamental milestone for Biomech Innovations. We are very proud to develop our Variable Fixation technology fulfilling current international quality requirements.”