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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Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
Blueprint Genetics; ISO 15189 – Quality Management System for clinical research laboratory
Team Kasve was responsible for building up a QMS to match ISO 15189 and US CLIA, Clinical Laboratory Improvement Amendments, requirements, and worked as an outsourced quality manager.