Certificates & Conformity

eg-zertifikat_marhythe

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

QM-Certificate

EN ISO 13485:2016 Medical Devices Quality management systems – Requirements for regulatory purposes

CB-Test-Certificate

CB Test Certificate

IEC 60601-1 (ed.3); am1
IEC 60601-1-6 (ed.3);am1
IEC62366 (ed.1);am1

Declaration of Conformity

Declaration of Conformity

EC-Declaration
of Conformity