Mindmore: Regulatory expert knowledge

Important results from the project

** Denna text är maskinöversatt ** By digitizing neurocognitive tests that test the brain´s various functions, Mindmore can screen for disease that affects cognition early in the care flow. In order for Mindmore to continue to reach out widely in healthcare and be used in more healthcare centers, the company needs to adapt regulatory processes and documentation to meet the new requirements according to MDR. Thanks to project funding from Vinnova, this has been largely met and Mindmore is better equipped to meet the MDR requirements in the spring of 2021.

Expected long term effects

** Denna text är maskinöversatt ** The Mindmore team has increased their regulatory knowledge and expertise regarding quality work in large part thanks to the project. Processes and documentation for quality work, risk management, technical documentation and clinical documentation have been created during the project. Some work remains e.g. update of Post Market Surveillance Plan to complete everything in accordance with MDR but Mindmore is well equipped to meet the requirements.

Approach and implementation

** Denna text är maskinöversatt ** Product Manager at Mindmore has coordinated the work with the regulatory consultants who were hired and other employees at Mindmore who have needed to be involved in various contexts to contribute with technical and clinical expertise. The consultants have in some cases worked most guiding and reviewing and in other cases where time or competence has been lacking at Mindmore, also defined processes and produced documentation.