Evira CE
| Reference number | |
| Coordinator | Evira AB |
| Funding from Vinnova | SEK 146 184 |
| Project duration | September 2020 - July 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
Implement and document quality management system (QMS) for CE-marking in accordance with updated European legislation.
Expected long term effects
Quality management system has been established, documented and introduced in the company´s workflows. The technical file has been updated. Evira currently meets the requirements imposed on the product by the updated regulation (MDR) and the company has acquired the competence required to maintain documentation and routines.
Approach and implementation
The work in the project was divided into work packages that were partly carried out in parallel: - Gap analysis - Update and document plan for QMS - Update technical file - Check and review of practical routines in accordance with QMS