I may accept what you are saying if you have any evidence to...

I may accept what you are saying if you have any evidence to back it up. First I invested in TIS. They knew trials were required for an FDA. They have always planned to this.
The CE mark (as far as they were advised at the time - trials were not required - otherwise it would have been made as clear as it just has been). I thought the CE mark was more a quality assurance for product manufacturing. Remember it was being passed as a device. They put it on a new electrical devices, but they don't need studies to prove it is better than what is on the market.

Perhaps you were clever enough to foresee the future beyond TIS management - well done. I wasn't and in retrospect you were correct.
Yes I blame management for getting it all wrong. But they have been advised by the BSI. I still think if they were told their data / trials were not adequate years ago, we would be at a different position.