If your medical product is equipped with RFID readers and RF telemetry modules or integrated into wireless networks, CETECOM can help you with the approval process: with a range of targeted consulting, testing and certification services. Meet the required quality, health, environmental and safety standards – for a fast and cost-effective market launch.
Testing of electromagnetic compatibility (EMC testing) is essential, especially for electrical devices for medical use. This is because it represents electromagnetic disturbance variables and thus provides a reliable basis for their elimination.
Our laboratory in Duesseldorf is accredited by the German Accreditation Body (DAkkS)* to perform EMC tests for technical medical devices. Thus we offer EMC testing services for electrical medical devices in accordance with the Medical Device Directive (93/42/EEC / 2007/42/EC) and Directive IEC 60601-1-2, 4th Edition. We issue test reports with the DAkkS and ZLG logos – for a high level of traceability at the certification bodies.
* Including the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
