Competence for Telemedicine and Medical Technology
Competence for Telemedicine and Medical Technology
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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