30.03.2020
C-Trend® software assessed to be in conformance with IEC 62304
The international standard, IEC 62304 “Medical Device Software. Software Lifecycle Processes”, is a key standard for the development of medical device software. Following a successful assessment process conducted with SGS Fimko, Cerenion's upcoming C-Trend® software was found to be in conformance with the standard.
"After working for more than a decade on software development projects for large medical device companies, I had the privilege to join Cerenion, a promising new company in the field. It was both exciting and rewarding to take part in building a software development process from the ground up", says Jussi Ala-Kurikka, Principal Engineer and development lead in Cerenion’s software development process.
"A high-quality, standards-compliant product and product development pipeline is an important factor for us in assuring our customers that they can trust Cerenion to meet their requirements", continues Dr. Eero Väyrynen, Cerenion’s Chief Technology Officer.
"This is a significant milestone for our quality management and software development operations", remarks Dr. Ilkka Juuso, Quality Manager and Chief Operations Officer at Cerenion. "It is also a great result for the 2-year project conducted in-house and with the help of the software and quality experts from Kasve Oy", he continues.
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.
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
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
https://www.kasve.fi
Highlights
This website and all of the content therein is for reference purposes only and is not intended to substitute for advice from a licensed healthcare professional. Not available in the United States. Cerenion™, Cerenion C-Trend™, C-Trend™, "The next-generation brain monitoring company"™ and "The pulse of the brain"™ are registered trademarks and/or trademarks of Cerenion Oy. Cerenion C-Trend™ is intended for use by qualified medical practitioners who will exercise professional judgment in its use. Cerenion technology is protected by Intellectual Property Rights. Patents pending worldwide. All rights reserved. © Cerenion Oy 2020.