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The system complies with the DIN EN ISO 13485 and DIN EN ISO 9001 international standards as well as with the EU legislation relating to medical devices. Besides, national regulations (e.g. by the FDA or Canadian law) have been fully integrated as well.
Checking product quality is an indispensable part of our quality measures. From receiving to final inspection, all products are subject to several checks and inspections at KLS Martin. At the time of completion, a 100% check is carried out in addition. Any deviations or deficiencies found, as well as customer feedback, are systematically utilized for improving our manufacturing processes and product quality.
For many years, KLS Martin has been operating a high-tech laboratory where check analyses and examinations are carried out and documented. Where necessary, we also work with well-known institutes as partners. This enables us to put materials and products to the acid test well before they reach the market.
Our lab staff is in a position to simulate even extreme instrument processing conditions, thanks to testing equipment (sterilizer, washer-disinfector) with special setting options. In addition to such lab work, our application engineers also offer qualified on-site testing, thus helping customers to optimize their processes in their own environments.
All our quality assurance efforts are rigorously centered on customer expectations, whether products, services or processes are concerned. As a visible token of our commitment to top quality, our products carry the CE-mark.
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