Quality Management System

We have implemented a total quality management system certified according to DIN EN ISO 13485, DIN EN ISO 9001 and the European legislation concerning medical devices. Of course, relevant national regulations have been taken into account as well - such as the requirements issued by the Food and Drug Administration (FDA) or the Canadian legislation.


Certificates for download

Karl Leibinger Medizintechnik GmbH & Co. KG

KLS Martin GmbH + Co. KG

Annex II of Directive 93/42/EEC

ISO 13485 : 2016 (MDSAP Audit Model Edition 2)

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