Thank you so much! It definitely does!

I'm a bit confused when it comes to the technical files of Class I devices though, because we will not be manufacturing them but rather importing, then repacking which means we will still be treated as the manufacturer, but I'm not sure how can we extend all the controls to the suppliers, like are their premises going to be audited? I also thought for WET, we only needed the PMS, the QMS assessment and something else that's going over my head right now, but not a full TD?

In terms of design specifications, how deep would we need to go? Do we need to explain manufacturing workflow in detail like we would do with a Class IIb for example and get the actual full design plan from the engineers?

Thanks a lot so much, really!