International preparations
| Reference number | |
| Coordinator | Monivent AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | November 2018 - October 2019 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: competence enhancement for smaller companies |
Purpose and goal
** Denna text är maskinöversatt ** In order to make the company better prepared for releasing the product on a broader market, the project objectives have been met by preparing a technical file and setting up a quality management system that meets the requirements in EU and provides a good basis for adapting to other markets. Internal competence and knowledge has been increased to be able to maintain the quality management systems, to set up new technical files in the future, and to know what is required when releasing the product in additional markets.
Expected results and effects
** Denna text är maskinöversatt ** With increased knowledge and expertise within the company, established processes and a more complete technical documentation, the company is now ready to proceed and begin the work towards releasing the product in additional markets outside the EU.
Planned approach and implementation
** Denna text är maskinöversatt ** The company has worked in close collaboration with the consultant in preparing and updating the technical file and quality management system, which has enabled a successful knowledge transfer to employees in the company. This will enable the company to independently continue to work on establishing and maintaining product documentation and the quality management system in accordance with regulatory requirements in further markets in the future.