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Certification according to EN ISO 13485:2016
The quality management system of Medicon eG has been certified by TÜV SÜD according to EN ISO 13485. This international standard describes the special requirements for quality management systems for medical device manufacturers and their suppliers.
With the certificate, TÜV SÜD confirms that Medicon eG, as a qualified medical device manufacturer, consistently implements the high standard specifications regarding the safety, quality and reliability of its products as well as the required risk management procedures.
The document of certification according to EN ISO 13485:2016 is available for you in the download center.
The certificate of CE approval confirms the design, manufacture and final inspection of the above products and product categories, thus granting approval for placing on the market in the European area.
The certified document of the EC certificate is available for you in the download center.