Quality

Meditera sees quality as a sign of respect for the world, the environment, humanity, human health which is its field of activity, future generations and itself. Due to its’ sectoral responsibility, it has created both its products and its quality management system according to the determined standards. The system and products it has created have been certified by notified bodies, certification bodies and competent authorities according to ISO 9001, ISO 14001, ISO 13485, 93/42 / AT and FDA 510 (k).

With the validated test methods in production, our products are maintained with the sampling method based on international standards and 100% quality control tests. In particular, our products are routinely tested for congestion, leakage and pulling.

Devices, machinery, equipment and molds used at every stage of production and that affect the life cycle of the medical device are included in our validation processes within a calendar framework.