Since 1996, our company has its own quality management system for medical device manufacturers, which complies with the requirements of the international EN ISO 13485 standard as well as the EU Directive 93/42/EEC on Medical Devices Annex II.
The design, purchasing, manufacture, final inspection and sales of a product during ongoing operation are tested and certified by an independent certification body based on clearly-defined and generally-applicable standards. The daily use of our quality assurance system ensures the greatest possible safety with regard to the properties of our products.
A part of our quality management system includes the regular measurement and evaluation of customer satisfaction that is carried out as part of visit reports or treatment documentation, for example. As a result, we can ensure that an optimum service is always guaranteed.
The issuing of the corresponding certificates for our company at the locations Cologne, Berlin and Munich, confirms that a quality management system has been introduced and is in use with regard to rehabilitation aids for laryngectomised and tracheostomised patients. It is subject to continuous review by the notified body.
Please find certificates here.