Competence for Telemedicine and Medical Technology


Certification


MEYTEC adheres to national and international standards and rules. As a responsible company we are obliged to comply with the strict criteria as it applies to the valid standardization of the development process. In addition we take the necessary steps required to create a customized and a long-lasting product for every user regardless of country.

Our focus is the design, development, production and marketing processes relating to national and international quality standards in the medical environment.

 

Norm Explanation

ISO 9001:2010

Minimum requirements to QM-System

ISO 13485:2010

Requirements to the medical products - quality management systems

DIN/EN 60601-1-2

Requirements to the main futures for medical electrical devices (e.g. EMV requirements and test)

German X-Rays Regulation (RöV)

Regulation for the protection from damage through X-Rays

Medical Devices Act (MPG)

Regulation for the placing of medical devices on the German market/implementation of European Directives 90/385/EWG, 93/42/EWG und 98/79/EG

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