Streifeneder Unternehmensgruppe

Quality Management

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.

Test laboratory

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.

Use the detachable item labels for documenting the products used on the Streifeneder patient certificate. In case of complaint and possible use of a warranty or guarantee for used goods, the patient certificate must be completely filled out and sent to Streifeneder ortho.production GmbH.

Orthopädietechnik Streifeneder Medizinproduktkennzeichnung

DEKRA-Certification

Our motivation is that you are enthusiastic about the design and quality of our products. To verifiably guarantee this, our company has successfully been certified for years according to EN ISO 13485. For you, the proof of our sustainable quality is a challenge for us, because due to the high requirements for medical devices inspection is performed annually. Our demand of ourselves to deliver faultless products is lived every day in our fields of development, production, quality assurance and sales and customer service. If you have any suggestions on how we can continue to improve, we look forward to hearing from you.

Orthopädietechnik Streifeneder DEKRA-Zertifizierung

Streifeneder ortho.production GmbH is AEO-F certified

The advance of globalization and changing security needs have prompted the World Customs Organization to introduce a so-called "Framework of Standards to Secure and Facilitate Global Trade" (SAFE). The basic objective is to secure the international supply chain from the manufacturer to the consignee.

As a global company, Streifeneder ortho.production GmbH has accepted this challenge and was certified in January 2013 as an "Authorised Economic Operator" (AEO-F) by the German customs authorities under registration number DE AEO-F 115235. We shall demonstrate with this that we live daily with compliance with customs regulations, the appropriate maintenance of accounting records, solvency and the required safety standards.

Through the worldwide recognized AEO seal we were classified as a trustworthy trading partner. As an AEO certified company, we are recognized by the customs as a secure trading partner and benefit from simplifications in the customs formalities. We are pleased that the certification helps us and our customers, customs processes and procedures to accelerate import and export activities as well as permits and licenses.

Orthopädietechnik Streifeneder AEO-F-Zertifizierung

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