mamivac is quality Made in Germany

Quality Made in Germany

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.

We are certified according to EN ISO 13485:2016.

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If you have any questions, we will be happy to help you