Kevtas, I share some of your optimism regarding Vitrogrow but at the moment I'm looking at how these recent events will affect the company TIS.
Things that worry me:
The sudden issue with the classification of the product. What if Vitrogrow is no longer deemed to be a device? Will the existing trials and product manufacturing data be enough to suit the new classification? If not, then TIS will have to do further work, which means more capital and a longer wait for sales.
People have a right to be really upset about these recent developments. We were told that the CE Mark was in the bag and all that needed to be issued was the piece of paper. I'm not suggesting this is poor management on the part of TIS - it's not because they were essentially passing on the advice given to them by BSI.
If it turns up that BSI has given TIS the wrong/bad advice and TIS has to go back and do further work (costing further money and delaying income from sales, PLUS maybe making existing manufactured product unsuitable for sale due to delays), how accountable is BSI for these errors? Would TIS be able to seek recourse from BSI?
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