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Start About us Quality


qualitaet

Merete´s supreme goal is to always provide safe products and services of highest quality to our customers, being surgeons, nurses and patients.

The achievement of these goals is monitored by our quality management team. The strict compliance with the specific requirements of the standards DIN EN ISO 13485 and 21CFR820 and Directive 93/42/EEC and the MPL is achieved via an integrated quality management system. We face this challenge and we are aware of our great responsibility.

Merete Medical GmbH is certified according to EN ISO 13485. Its quality management system is regularly audited by our notified body MedCert in Hamburg, Germany.  

In addition to the product development and production process, the hygienic aspects are very important components of our integrated management system. The compliance and effectiveness of the hygienic requirements in our clean room is monitored and documented regularly by certified microbiological laboratory tests according to GMP guidelines.

 

 

 

 

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