The device is going to have a CE mark (and hopefully FDA too, later). CE costs 50k USD, and you don't need human trials for such a standard device (you don't need to retest the efficiency of an electrocardiograph that does exactly the same as all the other ones, you just need to show that it does the same indeed). The investor is going to pay for it, and the business model is making money on the services instead of the device.
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The device is going to have a CE mark (and hopefully FDA too, later). CE costs 50k USD, and you don't need human trials for such a standard device (you don't need to retest the efficiency of an electrocardiograph that does exactly the same as all the other ones, you just need to show that it does the same indeed). The investor is going to pay for it, and the business model is making money on the services instead of the device.