Thanks to support from contracted Obelis S.A., the Company has been successful in obtaining a CE Mark designation in Europe. CE Marking serves as a declaration from a manufacturer that their product complies with the essential requirements of the relevant European health, safety, and environmental legislation laid out in the different product directives. It is the relevant European regulatory framework for medical devices to ensure conformity with current standards.
Obelis reviewed the Company’s documentation of test development, optimization, analytical and clinical performance, quality systems, commercial manufacturing characteristics, etc., and advised on compliance with current legislation. For more information, please see https://www.obelis.net/blog/what-is-the-ce-marking-process/.