What Is the Requirements for a Diagnostic Tool?

A diagnostic tool has probably different components, you, right? Because it did sitl you have ass all those requirements. And some of this is also unique to germany. An we have seen that with a couple of companies. They had already a product in other countries, and they had still to change it,. In order to meet the befam requirements. How do you want to let satisfy a patient if they say, yes, i i agree. I attend, or let jump into the study?