The truth about 2010
Yes, Sndy started talking about CE Mark on 2010 but couldnt finish and here is why!
1. According to Renee Vandenzande from Emergo Group, a direct Competitor of Expert Resources,
" in January of 2011 the requirements for CE Mark procedure changed significantly. From a simple 3 step procedure to a more complex and work intensive multi step procedure with a foreign body involved. Applicants and new Applicants have to follow these guidelines".
so, this is why it took much longer, and the president mentioned that in his letter, that the had to stop because of financial and technical reasons, fonancial because now CE mark procedure cost around 200 k compare to 30k
2 And technical reason was that they didnt have 2 years worth of testing with the Mammo View Unit
So that is the reason and the only reason for the delay!!! Yhese are facts and not some BS talk
And yes, ER said it typically takes 8 weeks in average after Audit 2 which in our case would be May 1st,
But, it could take longer depending how many technical files and CAPPA s must be reviewed. In the same statement they mentioned also that the company has 6 months timeframe after Audit 1! That would be september1st
Now the company released its updated schedule which says June 30 as final date. Well thats 60 days longer than the old schedule said but also 60 days less than what they could spend post Audit 1!!!
All cards are on the table after Audit 1 and I am sure ER gave them the expected max date for CE mark, I am pretty confident that this schedule is the final one and that June 30 is a generously calculated date by ER according where they are now!
I can live wit that, am sure they working like the Bees over at Solos to get this done, because they want to have a piece of that 40 billion European Endoscopy Cake!
And I am too,
Bonne Appetite!!. PS. The company also knows and is confident that they will succeed in Europe because of merger aquisition intent and because they have unique product with best technology at a far more competitive price as the EU
There is a huge market and why in the world would you spend all that time effort and $$$$ if you wouldnt be 100 percent convinced yhat you make it!!
They have unique products due to continued RD I am not concerned about revenues! They did what they had to do to get here, and they told us, and now we are close, so close I can sense the $$$
Great Great potential here, they didnt have the Mammo view and Steri Tap and Vegetarian line 25 years ago
These are all new products, and revenue goes up up up
They make it big my friends