Leyr - scalable access to health data
| Reference number | |
| Coordinator | Leyr Health AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | November 2022 - April 2023 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses 2022 |
Important results from the project
Aim and objective of the project were as follows: - Analyze Leyr´s product based on the market´s regulatory requirements, with a focus on MDR - Increase and maintain competence internally regarding current regulations - Design a strategy to establish the product on the market in parallel with the development of new functionality and implementation of a quality management system Through close collaboration with our regulatory consultant, we have been able to fulfil all of the objectives during the implementation of the project.
Expected long term effects
Together with our regulatory consultant, Leyr has met the objectives we set for the project. We have strengthened our internal competence and designed a regulatory product strategy to establish ourselves in the market. We have also started to implement a quality management system.
Approach and implementation
The plan and execution was as follows: 1. Analyze the product and future functionality based on current regulations, with a focus on MDR 2. Build a strategy regarding which regulatory requirements apply as the product develops and plan how we meet those requirements 3. Start implementation of quality management system