Regulatory approval and Quality system for CE marking
| Reference number | |
| Coordinator | OTORIX AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | October 2020 - September 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
** Denna text är maskinöversatt ** The overall purpose is to meet important medical needs worldwide through the development of new products in the field of hearing. The goal of this project has been to lay the regulatory foundation for new product systems in the hearing area. The goal of a completed certification according to EN 13485 has been met and thus a significant foundation has been laid for future launches of CE marked product systems in the hearing area.
Expected long term effects
** Denna text är maskinöversatt ** 1) A qualified quality and product development system 2) Certification of the company according to EN 13485
Approach and implementation
** Denna text är maskinöversatt ** We have worked according to our goal picture by taking in the resource we lacked and with that competence let Otorix build and work according to two work packages; certification of the company according to 13485 and a basis for CE-marked products.