Certificates & Declarations
Quality & Compliance first.
AUROSAN-Group is certified according to ISO 13485:2016, and for our own medical products (up to class II b) according to 93/42 / EEC.
Below, please find our quality certificates:
DIN EN ISO 13485
Vertrieb, Service und Reparatur von Medizinprodukten
Grosshandelserlaubnis und GDP-Bestätigung
Freiwillige Erklärung vom 14.03.2023 zum Lieferkettensorgfaltspflichtengesetz (LkSG)
Eingetragener Wartungsdienst für die Durchführung messtechnischer Kontrollen (MTK) an Medizinprodukten mit Messfunktion der Anlage 2 (MPBetreibV)
Eingetragener Wartungsdienst für die Durchführung messtechnischer Kontrollen (MTK) an Medizinprodukten mit Messfunktion zur Bestimmung der Hörfähigkeit (Ton- und Sprachaudiometer) nach Anlage 2 Nr. 1.1 (MPBetreibV)
In order to facilitate your own quality management, we keep the relevant documents for our products online (instructions for use, quality certificates, as applicable safety data sheets etc.): please visit our webshop at www.aurosan-shop.de.
Quality Management at AUROSAN
AUROSAN would like to support you with your daily work and routine. Our goal is to provide you with a comprehensive range of professional and flexible services and solutions that will make your workflow cost-effective and relevant. The AUROSAN product range is extensive and is regularly adapted to current standards and guidelines. This forms the basis for an always reliable fulfillment of your product requirements. All medical devices are of certified quality and meet the high demands of modern medicine as well as the requirements of the medical device guidelines and our own high quality expectations.
Certified quality: AUROSAN quality management is certified according to the standard DIN EN ISO 13485:2016. Our products are certified according to Directive 93/42 / EEC for medical devices and 98/79 / EEC for in vitro diagnostics. We accept only those contract manufacturers or suppliers who themselves have received quality certificates according to DIN ISO 9001 or DIN EN ISO 13485. This allows us to adopt your quality requirements and transfer them to our entire portfolio.
Quality Management with AUROSAN
In order to ease the operation of your own quality management, you will find for all our products as well as most traded products quality certificates and as applicable safety data sheets online available: freely accessible in our webshop www.aurosan-shop.de. The QM certificates and our declarations of conformity are also available upon request.
We will be pleased to answer your questions about quality management, the implementation of the RiliBÄK requirements or testing standards- by providing advice or practical training - you tell us what you need, we help. We also help with the creation and updating of your quality management system and manuals.
Finally, you may approach us for a full-day „Praxischeck“ accelerating your team’s performance and public perception. Read more here. For further information do not hesitate to contact us at any time.
Quality management stands for the ambition of continuous improvement. Ourselves, we are eager to listen to your suggestions and product ideas, and we will implement them as far as possible, in order to constantly adapt our company’s development to our customers’ needs. All AUROSAN employees are involved in improvement processes, which ensures the necessary competence in our dialogue with you.
Technical Service - Documentation, maintenance and repair of medical equipment
In addition to the distribution of our medical products, through our subsidiary RÖSCH Medizintechnik in Berlin, we also offer support for the implementation of the Medical Device Operator's Regulation (MPBetreibV) with regard to documentation (equipment manual) and organization. Moreover, RÖSCH Medizintechnik is a registered, manufacturer-independent repair and control service provider for medical devices, and qualified by numerous manufacturers for the maintenance and repair of their medical devices.
As such, between AUROSAN and RÖSCH we can support you for safe, product- and equipment-aligned processes in your office and laboratory - for the benefit of your patients and for a trouble-free next third party audit.