Leyr - scalable access to health data

Purpose and goal: 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 results and 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