Madonion87 'Once CE finish asking their questions you're either granted or rejected. It's not going to be another 2 years'
I fear you do not understand the CE process. There is no concept of rejection in the pure sense. The NB will continue to work with an applicant for as long as the client is prepared to keep paying the bills. I have known of cases where the NB feels the client is not going to make it and advised them that maybe a different NB may be considered. There are limited NB with experience with implantable radioactive medical devices, and so BSI has few alternatives.
'It's not going to be another 2 years'
Probably true, but not impossible.
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