RE:RE:RE:RE:RE:RE:Dermal Injector Roll-outInv3strr wrote:
Not in this case.... we already know that AMI is making the RCI injectors and AMI is a company that specializes in CE marks and medical devices... When AMI started making the RCI they were thinking about how to make it so they could get a CE mark... they wouldnt make it with the wrong plastic or with materials that would be rejected for a CE mark. They buildt it with the CE mark goal from the beginning. Thats what AMi does.
CE mark is most important testing right now and they can do that without the commercial grade devices.
The End user testing will happen later,,.. but thats for the marketing. So they can say that it is 99.8% accurate with dosage compared to 78% accuracy with normal needles. Or that it reduces need for anesthetic by 99% of injections. Or that it enters the skin layer at a 100% accuracy rate. Or that it reduces infections by 99% compared to normal needles that have a 78% infectino rate.... Thats a different kinda testing than what they ar doing now...
I worked on a project with a CE mark for my university a couple years ago... the most important thing was that a device doesnt catch fire or electric shocks.. also that it has zero types of certain chemicals that are actually really hard to eliminate in materials. Like metal has lead and plastic has impurities.
AMI knows all of that .... they used the right materials from day 1 or they wouldn't be making medical devices.... also they make med devices not just for replicel they make other medical devices for themselves and other companies too.
Again I dont doubt what your saying, you seem to have firsthand knowledge of attaining a CE mark. My point is that replicel release info that is misleading to the average investor. Misleading in the respect of not giving specifics so we have to make assumptions