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 (e.g. regarding electrical safety).
Furthermore, UL periodically inspects our manufacturing facility to verify that we continuously meet the stringent UL quality standards.Furthermore, the safety and performance of SenTec products, e.g. regarding biocompatibility, electromagnetic compatibility and measuring performance, is tested by independent laboratories.
SenTec has been inspected by our Notified Body (TÜV SÜD), US FDA, and other international competent authorities to ensure that our products fulfill regulatory requirements such as the European medical device directive (MDD 93/42/EEC), the ISO 13485 regarding Quality Management Systems and applicable standards throughout the entire product life-cycle.