ISO 13485 & CE MARK CERTIFICATION

Menicon acquired certifications of compliance with ISO13485 and CE Mark

As part of this certification process, the German notified body "mdc" undertook a stringent audit of the head office of Menicon as well as Menicon Europe and Menicon GmbH.

The companies passed these intensive audits and received certifications of compliance with the ISO 13485 which is quality management system standards prepared by the International Organization for Standardization (ISO).

We also acquired certification allowing use of the CE Mark, which indicates that the product conforms to the European quality assurance standard.

We also acquired certification allowing use of the CE Mark, which indicates that the product conforms to the EU Medical Device Directive (MDD).