Key ISO 13485:2016 certification awarded to Cerenion
Oulu-based Cerenion has received official certification for its Quality Management System (QMS) under the international ISO 13485:2016 standard.
The certification resulted from a 2-year project partly funded by the European Regional Development Fund of the European Union. The QMS was developed in collaboration with the Kuopio-based quality consultancy, Kasve Oy, whose expertise helped Cerenion tailor a QMS to match its needs.
Cerenion Oy has developed the world’s ?rst practical method for measuring the brain function of intensive care patients. Cerenion’s patented C-Trend® technology reveals the status of the brain as one simple score – at the bed-side and without requiring any changes to the care of the patient. The solution works by combining standard EEG-measurement with advanced machine learning algorithms and artificial intelligence. The technology has the potential of improving both the quality and the cost of intensive care.