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Information about our quality management

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We are convinced that our focus on technical innovation and development is the key to continuous product improvement and therefore optimal patient care. In order to offer our customers exactly the high-quality products they need, we hold ourselves to high standards and fully comply with all legal and regulatory requirements.

We strive for total quality

Our many years of experience and the certified quality management system introduced in 1998 compliant with the DIN EN ISO 13485 standard guarantee the quality of our products and the corresponding processes throughout the company.

Certified test laboratory

Functionality and safety are key aspects for medical devices. We conduct in-house tests according to DIN EN ISO 10328* to verify this for our products in prosthetics. Our test laboratory certified according to DIN EN ISO 17025** is available for this purpose.

* Structural testing of lower limb prostheses
** For test laboratories

Declaration of conformity

Our declaration of conformity confirms that the identified products meet the requirements of Regulation (EU) 217/745 (MDR). To meet documentation requirements, please apply the self-adhesive article labels of the articles used to the patient certificate and fill out all of the patient information.

Self-adhesive article labels

Use the self-adhesive article labels for documentation of the products used on the patient certificate. In case of a complaint, this customer/patient documentation serves as proof of compliance with all mandatory technical directives for the construction of a prosthesis and of meeting the legal requirements of the medical device law. In the event of a complaint and any warranty or guarantee claim for used goods, the patient certificate must be completed in full and sent to Streifeneder ortho.production GmbH.

Certifications

EN ISO 13485

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. (Certificate download at the bottom of the page)

AEO-F

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.