Description
The topic of this booklet is basic regulatory knowledge. It is about the regulatory basics when launching digital biomarkers, medical devices, SaMDs or IVDs on the market. This topic will be looked at from different angles and perspectives in the following chapters. We will try to answer the question of how a start-up or an already established company can bring medical devices to market that can be successful in the market, help the patient and ideally unburden the system and bring profits to the company.






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