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Certificates & Conformity
The Matrixmobil ® and the Matrixmobil alpha-synchronizer® are the only medical devices for the application of Matrix Rhythm Therapy (MaRhyThe ®). Active medical devices are subject to special requirements. These requirements serve to ensure the safety, health and protection of patients and users.
As a manufacturer, we have a quality management system and are certified in accordance with EN ISO 13485:2016.
EC-Certificate
Quality Assurance System
Transition MDD to MDR: Product-Directive EU2023/607 – EU 2017/607 – EU 2017/745 MDR, as well as Product Directive 93/42/EWG on Medical Devices (MDD), Annex VI (Devices in class IIa or IIb); CL 035504 0015 Rev.00 (for GS 035504 0011 Rev.00) valid till 2028-12-31
QM-Certificate
EN ISO 13485:2016 Medical Devices Quality management systems – Requirements for regulatory purposes –
CB Test Certificate
IEC 60601-1 (ed.3); am1
IEC 60601-1-6 (ed.3);am1
IEC62366 (ed.1);am1
