TeMeCo supplies high-quality and innovative medical devices for cardio-diagnostic examinations at the patient’s home. Patient safety is essential. The starting point for TeMeCo is that its solutions meet the legal requirements and guidelines. Therefore, the quality management system of TeMeCo is certified against the ISO 13485:2016. This means that the quality management system is appropriate and effective while emphasizing the safety and efficacy of medical devices.

The SenseLink technology is certified as medical device and holds a CE certification against the MDR. The certification is issued by Kiwa Dare B.V. (1912) as Notified Body. Under the Medical Device Regulation 2017/745 (MDR), we carry out various activities to continuously monitor the safety and performance of our medical devices. Post-market surveillance (PMS) takes place throughout the equipment lifecycle.

TeMeCo is also registered in EUDAMED (European Database on Medical Devices) as “manufacturer of medical device”s with the following SRN: NL-MF-000011503.

ISO 13485 TeMeCo