Sounds like a complete cop out to me. All this bull sheet about a small sample. It was BSI that insisted on 20 patient data. The company went beyond that and provided over double!
The data requested by BSI stated they wanted safety data. The company provided safety data!
Looks like the company has been bull sheeted to. Nothing more then this company can do now. I won’t be surprised if the lawyers will be called in. I reckon There will be litigation if this can’t be resolved soon.
Ann: CE Marking Update, page-51
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