Quality Assurance at AGA
At AGA, great emphasis has always been placed on product safety. Our products are developed, manufactured and assembled exclusively in Germany and comply with German and European quality and safety standards.
As early as 1993, part our products received the GS sign (for approved security) by RWTÜV. Since then, the scope of approved products has increased continuously. Nowadays, the GS sign may no longer be attached to medical devices in conjunction with the CE label.
CE Conformity
We hereby declare that our products, to be classified in Class I due to their design and construction as well as the versions we have placed on the market, comply with the relevant provisions of the Classification Rule, Rule 1 according to Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Annex VIII.
The conformity assessment procedure is in accordance with Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Annex IX. Our products are therefore provided with a CE mark. The declaration of conformity shall lose its validity if the products are modified in any way without our agreement.
Quality Management
QM Certificate for Medical Devices according to DIN EN ISO 13485:2022
In October 1995, AGA Sanitätsartikel GmbH was certified according to DIN EN ISO 9001 - DIN EN 46001 by the Landesgewerbeanstalt Bayern (LGA) as one of the first companies in its field.
In June 2006, the company received the QM certification for medical devices according to DIN EN ISO 13485:2003, issued by LGA InterCert.
In June 2019, MDC Medical Device Certification GmbH has certified that AGA Sanitätsartikel GmbH has introduced requirements for regulatory purposes in the fields of development, production and distribution of medical furniture and applies a quality management system for medical devices in accordance with DIN EN ISO 13485:2022. The certification has verified that the management system fulfills the requirements of the above standard.
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