Certifications

Made in Germany – Our Certifications!

Enverdis GmbH undergoes an annually certification process according to the normative for medical device manufacturers to EN ISO 13485 and compliance with the legal requirements by the MPG (Medical Devices Act) and the EC 93/42/EEC (European Directive).

The continuous development of our quality standards is our primary target. In this way we ensure the assurance tested quality and a high degree of transparency for our customers and users.

 

 

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Export Initiative for German Health Care Industry

Germany Trade and Invest
Friedrichstraße 60
10117 Berlin

Further information:
www.health-made-in-germany.de

 

 

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CE is a symbol of new ways of thinking

CE indicates compliance with
all fundamental safety and
health requirements.

Further information:
CE certification enverdis

 

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ISO 9001
/ ISO 13485

Quality management (QM-System)
Manufacture of medical products

Further information:
ISO 9001 Download
ISO 13485 Download

 

 


Certificate of Marketability MDD

12-016 according to the Council Directive 93/42/EC
of the EU Parliament of 14.06.1993 for medical devices