A service for the future way of finding and preventing heart disease
|Funding from Vinnova||SEK 200 000|
|Project duration||January 2019 - June 2019|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The purpose of the project was to investigate the regulatory demands and take the first steps toward fulfilling these for a new product in Linkuras offer. Together with the regulatory consultant Medos AB a product claim and a clear path towards certification was defined. From this point the project parties developed a quality management system (QMS) built to adhere to the requirements for a medical CE certification class IIA according to MDR. In summary the project met all goals and is considered a success.
Expected results and effects
The product claim was defined as “The service will diagnose and reduce the occurrence of dangerous cardiac arrhythmias”. This claim describes a service that diagnoses and monitors a non life threatening condition with a classification as a medical device IIA according to the MDR. The project has also developed a QMS ready for implementation and a substantial increase in the regulatory competence for Linkuras staff.
Planned approach and implementation
The project was completed in good spirit with Medos AB, Linkuras Business Developer Tobias Widemar and Product Owner Åsa Tjernvik. The project followed the set plan and reached all expected results and effects. The continuous transfer of regulatory competence from Medos to Linkura was also a central part in the success of this project.