Helen - Medical Communication Device for Equal healthcare
|Funding from Vinnova||SEK 200 000|
|Project duration||August 2019 - February 2020|
|Venture||Medtech4Health: Competence Enhancement in SME|
|Call||Medtech4Health: Competence enhancement for smaller companies|
Purpose and goal
The purpose of the project is strengthen the company´s competence and knowledge in medical regulatory aspects, quality assurance and CE certification processes needed for its medical product and organization.
Expected results and effects
At the end of the project, the company should have a developed 1)standardised quality management process, 2)medical regulatory knowledge for CE applications and 3)must have a technical file ready to submit for approval for a CE class 1 marking. Additionally the company should be internally better prepared for future regulatory changes and GDPR related aspects. At the end, this would contribute to a safer medical product and a more standardised development and quality control process in the company.
Planned approach and implementation
The project will consist of several workshops together with medical regulatory consultants covering preparation, development of certain quality management, GDPR considerations and standardization of product development processes. The certification preparation processes would also include medical verification, risk analysis of the tool,technical documentation and writing an application for a CE application.