Product Safety

Every product development at SenTec begins with close customer consultation as well as determination of the regulatory and statutory requirements. The evolving product designs are realized in state-of-the-art technology. Quality tests based on internationally recognized standards ensure high product quality and patient safety. Being aware of the importance of product quality and safety we furthermore monitor our performance and processes closely.

The SenTec Digital Monitoring System is certified by UL (Underwriters_Laboratories). The Canada/U.S. UL Mark on the SenTec Digital Monitor signifies that UL has tested and evaluated representative samples and determined that the SenTec Digital Monitor meets UL’s requirements. Furthermore, UL periodically inspects our manufacturing facility to verify that we continuously meet the stringent UL quality standards.

Periodic inspections are also performed by our Notified Body (SGS SA) to ensure that our products fulfill the requirements set forth by the European medical device directive (MDD 93/42) and applicable standards throughout the entire product life-cycle.