Sorry to hear about your loss, but can you please stop going on about that company. It's like trying to compare apples with oranges there are no comparisons between the two. RAP's device is for a class IIa application, non invasive, low risk mobile phone application. RAP's device itself is safe to use and is already in the pockets of billions of people worldwide it's the application itself that just has to pass. IMO we are about 90% over the line already with ISO 13485 under our belts European device applications are classed in a few different types of categories: Is, Im, IIa, IIb and III medical devices... RAP double blind studies had a much larger study group compared to the other company. The other company trying to achieve clearance sounds so much more complex compared to this company. It also sounds like their device is invasive and thus is probably class 3....
No matter what happens mate all the very best, it's not always going to be bad luck all the time....
Cheers
Red bar
Sorry to hear about your loss, but can you please stop going on...
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