Menicon acquired and maintains certifications of compliance with ISO 13485 and European Medical Device Directive (MDD).

The German Notified Body "mdc" audit Menicon's Quality Management Stystem on a regular basis, to verify and confirm that all regulatory requirements for manufacturing of Medical Devices are met.

Menicon successfully passed these intensive audits and received certifications of compliance for the established Quality Managemen Stystem according to ISO 13485 (ISO 13485: Medical Devices - Quality Management Systems - Requirements for regulatory purposes).

As a part of this certification process, "mdc" as Notified Body certifies that Menicon's Quality Management System is in conformity with the European Medical Device Directive (Council Directive 93/42/EEC concerning Medical Devices). As a result, Menicon is authorized to label their manufactured Medical Devices with CE Mark.