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.
Read more references
With the help of Kasve, we developed a marketable medical device in a year
Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.
Growth requires a quality management system
Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.
A comprehensive partner for the establishment phase
Kasve accompanied the preparation and establishment phase of Neurocenter Finland.