![eg-zertifikat_marhythe](https://marhythe-systems.de/wp-content/uploads/eg-zertifikat_marhythe1-80x80.jpg)
EC-Certificate
Product Quality Assurance System
Directive 93/42/EWG on Medical Devices (MDD), Annex VI (Devices in class IIa or IIb)
![https://marhythe-systems.de/wp-content/uploads/QM_Certificate_EN-ISO_13485_2022.pdf](https://marhythe-systems.de/wp-content/uploads/Certificate_EN-ISO-13485_2016_MaRhyTheSystems-80x80.jpg)
QM-Certificate
EN ISO 13485:2016 Medical Devices Quality management systems – Requirements for regulatory purposes
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CB Test Certificate
IEC 60601-1 (ed.3); am1
IEC 60601-1-6 (ed.3);am1
IEC62366 (ed.1);am1