From the beginning, we have built our QM system based on a process-oriented approach.

As a consequence, the German DEKRA institute certified Kimetec as manufacturer of medical devices and provider of related services in accordance with the medical device standard EN ISO 13485:2012 + AC:2012. This is the internationally recognised standard for quality management systems in the medical device industry.

The standard specifies requirements for a quality management system intended for use by organisations for the design and development, production, installation and servicing of medical devices.