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.

“This was a massive project that proved both taxing and rewarding in equal measures,” said Dr. Ilkka Juuso, Quality Manager and Chief Operations Officer at Cerenion. “We looked to the standards and both European and American regulations as our tools in building our processes with quality, safety and performance in mind. Our challenge, and also our good fortune, was that we did so from the ground up,” he continued.
“It became very clear from the beginning of our joint project, that the Cerenion team is exceptionally talented, motivated and ambitious. It was our great pleasure and honour to give our input and utilise our expertise on the road towards the functional and certified QMS.,” commented Dr. Nina Vartiainen, Quality Affairs Director at Kasve Oy.
The Cerenion QMS was audited and certified by SGS Fimko according to the ISO 13485:2016 standard. The QMS also incorporates key features from other relevant international standards including ISO 14971 and IEC 62304.

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.

Source: Cerenion

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