Numa - global support for new mothers
| Reference number | |
| Coordinator | Bestla Health AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | February 2024 - March 2024 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses 2023 |
Purpose and goal
** Denna text är maskinöversatt ** Numa is a CE-marked, evidence-based digital platform that guides & supports new mothers regarding their own health and has been launched on the Swedish market. The purpose of the project is to increase the internal competence around the regulatory eligibility requirements that exist for medical devices outside the EU in order to reach more markets and to carry out adjustments to the platform to ensure compliance with regulatory and safety eligibility requirements on an international market.
Expected results and effects
** Denna text är maskinöversatt ** The project is expected to strengthen the internal competence regarding international regulation of medical devices. This means developing and implementing routines for clinical and technical documentation as well as updating technical roadmaps to meet international regulatory and safety eligibility requirements.
Planned approach and implementation
We launch the project with workshops and interdisciplinary knowledge transfer to bring together key stakeholders, including product owners, developers, midwives, regulatory experts and patient representatives. By working closely with external consultants, we ensure that we effectively map and understand the regulatory requirements. We will ensure that we clearly make use of this knowledge and update the plan for the implementation of the project, including follow-up and strategies to maintain the necessary knowledge within the company in the long term.