&gt; How is it you &quot;go hoarse having the same conversations?&quot; Do you not have to meet FDA compliance criteria? Are you in the US?<p>You have to deal with FDA pretty much regardless where you&#x27;re based, if you want any kind of market for your medical device. A lot of countries define compliance as whatever is good enough for FDA.<p>FDA rules for software... what FDA wants is a paper trail.