Fulfilling regulatory requirements for an IT System enabling followup after childhood cancer
| Reference number | |
| Coordinator | Concidera Health AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | September 2020 - March 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 project´s objective was to use external expertise to: 1) Identify the product´s workflows and 2) Complete files so that the product and the company meet regulatory criteria according to MDR. The project aimed to strengthen the position of Concidera Healths´s product and bring it closer to the market.
Expected long term effects
** Denna text är maskinöversatt ** In accordance with the goals, the CiCADA system and Concidera Health now meet the regulatory criteria that enable market introduction and market access until 2024. In the customer contacts the company has had, the regulatory documentation has been an important milestone.
Approach and implementation
** Denna text är maskinöversatt ** The project has followed the project plan with 2 work packages, and a relatively good timekeeping. A minor delay occurred early, which affected the end date (which was flexibly adjusted together with the funding source). Within the project, we have had a good collaboration with the external expertise and a excellent dialogue within the company.