CE marking

So that has to be kind of worked up at some point, one point or another, either if the business case looks likely to be signed off or after it's been signed off, but prior to implementation of the solution.

And what is FDA clearance, CE marking, ISOs? What does that mean to the individual?

Yeah, they all focus on data security and patient safety data.

But I'll let Sean explain this a little bit.

So what these mean is that healthcare providers can then trust the technology that's being brought in to help and it's not adding any significant risk.

And I understand that there's slightly different regulations whether or not you're a medical device and therefore directly supporting to lead to a diagnostic or a treatment outcome versus something that's more around wellbeing and clinicians need to kind of explore with providers and suppliers around whether or not their device is legally a medical device or if it doesn't fall under that category.

And just going to what you said as well around the CE marking, that's what we would expect in the UK at the moment.

I understand that we're moving towards a UK CA approval as well, which is the UK version post-Brexit, but hasn't yet been integrated.

So the team came together and brought that in.

I myself am also a special operator of the IDF, have a master's in genetics, and came to the game from kind of more deep healthcare side of things, but came to commercialize the product as well as the CEO.

Wow.

Interesting.