QM-System
QM-System

For almost 20 years ALBOMED® GmbH has developed, produced and distributed medical devices of all risk classes according to the European Medical Devices Directive 93/42/EWG.

When working with our co-operative partners and suppliers we insist upon the same requirements that we place on the quality of our own products. In addition to legally required monitoring surveys we also conduct unannounced inspections as well as regular audits on-site at our suppliers. We do not rely solely on certificates: we also demand compliance with additional standards such as Pharmacopeia or GMP. The detailed and customer oriented QM-system of ALBOMED® GmbH has been certified since 1997, producing medical products in accordance with the requirements of CE certification. Our QM-system is subject to regular internal and external audits.

Continuous development of processes, swift response to market demands and the rapid implementation of legal requirements, together with the personal engagement of all our employees, guarantees the consistent high quality of our products. Over many years ALBOMED® GmbH has worked together with the company ECM in Aachen as a well-respected Notified Body to maintain the highest German standard in certifying our QM-system.

ALBOMED® GmbH is ISO DIN EN 9001 and ISO DIN EN 13485 certified.

If you have any questions or would like further information please send us an inquiry.

Next Congress
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American Society of Cataract and Refractive Surgery
5 - 9 May 2017
Los Angeles, USA

Website of organizer 30th International Congress of German Ophthalmosurgery
11 - 13 May 2017
Nuremberg, Germany

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