Quote from: belechau on December 19, 2017, 08:14:35 PM

Quote from: matjas on December 19, 2017, 08:00:49 PM

Quote from: weekofcrypto on December 19, 2017, 07:53:46 PM

Quote from: Sozialtourist on December 19, 2017, 02:21:41 PM

Quote from: openair on December 19, 2017, 01:25:09 PM

I dont think FDA approval is needed, its usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

I wouldn't think FDA approval is needed, but I bet they need a disclaimer about the results not being medical recommendations and to consult a doctor first.

They really need to think it all through. Sanitary rules, instructions, extra emphasize on accuracy of results and the distribution network. This project needs a lot of careful planning in order to succeed.

It is really necessary to take care not to run over some legislation, especially if your work product is exposed with supervision of people who do not master the concept, there may be some complexity in, current legislation, issues related to hygiene and basic attention to the 'Patient' . In a way this will require a lot of work in the virtual world and even more in the real world, the Team will be working in double and this requires a lot of will power

Of course there are going to be diferent laws the have to obey and they change in each country, but that is something that the designers of the device have already had to take into account when they developed it.