Quality work - the focus of our company philosophy
The products of our company serve the purpose of supporting high-quality medical care. Against this background, the quality of our work is of paramount importance. Our quality assurance procedures reflect international standards and the special demands placed on medical products, and have been certified since 1998. In accordance with the latest developments in the field, we meet the demands of DIN EN ISO 13485 in conjunction with the European Medical Devices Directive 93/42/EEC. By way of re-certification and annual monitoring audits, we have demonstrated that we view quality assurance as a continuous process of further development and improvement. Risk management in accordance with DIN EN ISO 14971 is integrated into our quality system.
This is the basis for the CE marking carried by our medical products. They are classified as Class I and Is products. In accordance with the applicable national and international regulations, all medical products are monitored and tested both during and after the manufacturing process. In the case of Class Is products, external monitoring in accordance with the EC directive 93/42/EEC, Annex V is carried out by the Notified Body 0197.
Our suppliers are selected to ensure from the beginning that only quality-conformant materials are used in the manufacturing process
Our staff have received special training for their responsibilities in connection with sterilisation and work with ultimate quality awareness. You are able to rely on a validated sterilisation process.