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A service for the future way of finding and preventing heart disease

Reference number
Coordinator LINKURA AB
Funding from Vinnova SEK 200 000
Project duration January 2019 - June 2019
Status Completed
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.

External links

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 20 December 2018

Reference number 2018-04857

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