We know that informed bodies, w/any required 3rd parties (like ISO registrars), regulatory agencies require an established system be in place (21 CFR part 210 & 211 A,B...). It all suggests the next phase of getting AVXL structured and staffed to comply w/requirements. We all understand that virtual structures can be accepted, we do not need an army, but we are required to have a story to tell. it's all good.