ISO 13485:2016 Medical Devices

 We Are ISO 13485 Certified!


OPTIKA has been proudly achieved the ISO 13485:2016 certification, an internationally recognized medical device quality management systems standard, which was awarded us for our design, development, manufacture and supply of microscopes for medical and diagnostic applications.

The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. We have developed and implemented our quality management system. Our decision to work towards the ISO 13485:2016 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our clients. The ISO 13485:2016 certification is the assurance that we work according to the latest standards and regulations, also so that we can assure you as our partner that we have robust, clearly defined procedures in place.


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