Da there are many regulations, laws and regulations, and authorities that As an entrepreneur in health and healthcare, you need to have knowledge of. We know that it is difficult to understand what influences just you and your solution. Our goal is to prepare entrepreneurs early in the development process to facilitate dialogue with the public sector at a later stage. We can therefore support you with to figure out how your solution is classified, which in turn affects for example management routines, what documentation needs to be available and what requirements are set regarding security. If the solution is classified as a medical device is it affected by EUthe regulation MDR, Medical Device Regulation. This one rackyour high demands on security and stability, which is good to be aware of as early as possible.
The regional project DigitalWell is financed by the European Union - European Regional Development Fund. The purpose of DigitalWell is that we will together develop digital solutions for needs in welfare with the user's own abilities in focus.