Cerenion: ISO 13485:2016 Quality Management System
Cerenion is university of Oulu based spinoff that develops algorithm for monitoring patients’ brain activity and functionality as part of EEG equipment. Cererion’s product is a medical device that is utilized by EEG manufacturers in order to provide care givers with vital information in easily understandable format.
Team Kasve build up together with Cerenion key personnel ISO 13485:2016 quality management system that, for example, enhances company’s R&D activities, risk management and training of personnel. Team Kasve also participated into creation of software development documentation and was responsible that requirements for medical device software documentation were met.
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