We are convinced that only constant technical innovation and development is the key to continuous product improvement and optimal patient care. For each of our customers in order to be able to offer high quality products that are needed, we set high standards. All our products are subject to continuous quality planning, guidance, control and improvement. In order to satisfy individual customer requirements and to close product-related gaps in the market, it is imperative that our own production series be available in large, but also very individual quantities.
We demand integral top quality of ourselves
Our 80 years of experience and the quality management system that was introduced in 1998 and is regularly certified according to DIN EN ISO 13485 ensure the quality of our products at the highest level. We have developed our quality management system into an enterprise-wide system. Because of this we get our usual high level of quality and expand it further in order to meet the increasing demands of our clients in the development, production and safety aspects.
We have an externally certified test laboratory according to DIN EN ISO 17025 (for test laboratories). In the test laboratory, we facilitate tests according to DIN EN ISO 10328 (testing of the structure of lower limb prostheses), immediately implementing demands in leg-prosthetics and therefore continuously improving the continuously high quality standards of Streifeneder prosthetic components.
For us, this is an important aspect of our understanding of perfect products – for you as customer, it is an important characteristic that we test and develop our products contemporarily, innovatively and always under the aspect of integral quality.
Declaration of conformity
Streifeneder ortho.production GmbH as manufacturer declares its sole responsibility that the products identified as such comply with the requirements of the Medical Device Directive 93/42/EEC. For documentation requirements please stick removable item labels for the items used on the Streifeneder patient certificate and completely fill in the patient data. Based on this customer/patient documentation, compliance with all required technical guidelines for the construction of a prosthesis and the fulfilment of the legal requirements of the medical devices legislation can be proven in cases of disputes.