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slazenger7

02/21/13 10:06 PM

#51123 RE: yip9lives #51114

This audit is just one of three audits that need to be completed. This audit is just the Stage 1 Audit (Document Review). They still have the Internal Audit which is a Full System Audit, then Corrective Actions to Internal Audit, and then the Stage 2 TUV Audit.

This first document review audit, which was originally supposed to be completed in October of 2012, is being touted by some as some kind of earth shaking accomplishment, as if it was the CE Certification itself. Its not even close.

Here is the second set of bar graph schedules put up on the company website. The first set had them completing everything in November of 2012. The didn't even come close. Now they say April 2013. Good luck!

http://www.solosendoscopy.com/pdf/SNDY-ISO-13485-CE-Mark-Project-Schedule-October-2012.pdf

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