Key ISO 13485:2016 -certification awarded to Cerenion’s Quality Management System
Following a 2-year project partly funded by the European Regional Development Fund of the European Union, Cerenion has now received official certification for its Quality Management System (QMS) under the international ISO 13485:2016 standard. The QMS was developed in collaboration with the Kuopio-based quality consultancy, Kasve Oy, whose expertise was instrumental in helping Cerenion tailor a QMS to match its needs.
"This was a massive project that proved both taxing and rewarding in equal measures", says 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 continues.
"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.", says Dr. Nina Vartiainen, Quality Affairs Director at Kasve Oy. Dr. Vartiainen, Jani Hopia, Elias Haapakorva and others from Kasve worked closely with the Cerenion team led by Dr. Juuso over the duration of the project.
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.
"This certification now granted is a major step for us towards the international market, where ISO 13485 quality management is a requirement for doing business", concludes Dr. Jukka Kortelainen, CEO of Cerenion.
Cerenion gratefully acknowledges support from the European Regional Development Fund of the European Union and the Centre for Economic Development, Transport and the Environment in North Ostrobothnia on the development of its quality management system and the related work in seeking the appropriate regulatory approvals and bringing the Cerenion C-Trend® index to the international market.
Cerenion Oy has developed the world’s ﬁrst 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. http://www.cerenion.com
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 94,000 employees, we operate a network of more than 2,600 offices and laboratories around the world. https://www.sgs.com
Kasve is an expert organization for the health technology sector. Kasve provides digital tools and services for tackling the quality, regulatory and business development challenges of medical device companies. https://www.kasve.fi
Cerenion Oy has received support from the European Regional Development Fund of the European Union.
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