CE marking for a digital journal system
| Reference number | |
| Coordinator | Ahum AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | January 2018 - May 2018 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The aim of the project was to establish routines and processes in line with the Swedish Medical Products Agency´s requirements for Class 1 medical devices with the goal to obtain a CE-mark of Ahum.
Expected results and effects
In the project, processes and procedures according to Swedish Medical Products Agency´s requirements for Class 1 medical devices have been set up. As a result, Ahum has ensured a confidential and patient-safe handling of patient data.
Planned approach and implementation
The project started with a risk analysis, which led to a requirement and improvement list together with a new documentation management system. Requirements and improvements identified during risk analysis was implemented resulting in Ahum´s compliance with Swedish Medical Products Agency´s requirements for Class 1 medical devices.