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. 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.

Conformity evaluation in accordance with Medical Devices Directive 93/42/EC

Conformity with the requirements stated in the Directive 93/42/EC is mandatory for selling medical devices within the European Economic Area. Kimetec was reviewed whether these requirements were met. A CE mark on the medical devices indicates that our products passed the test. Depending on the risk class of the certified product, an institute named by the EU has to be charged. We co-operated with DEKRA Certification GmbH as competent service provider.

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