$SNDY - How many OTC's do you know have FDA approv
Post# of 94265
8-12 weeks from the Stage 2 audit puts us AT OR AROUND TOMORROW!
BOSTON, MA--(Marketwired - Oct 8, 2013) - Solos Endoscopy, Inc. (OTC Pink: SNDY) is pleased to announce that the Company has passed its Stage 2 audit with Notified Body and registrar TÜV SÜD for registration to ISO 13485:2003. The Stage 2 audit was conducted August 15 - 16, 2013. TÜV SÜD found no non-conformities to Solos Endoscopy's Quality Management System requirements in the audit.
Solos Endoscopy is now in the process of drafting Technical Files and associated documents for the MammoView® devices the company intends to sell in Europe. TÜV SÜD will review the Technical Files for Solos Endoscopy's sterile devices in the MammoView® system. Since the Ductoscope is a Class I device in the European Union, Solos Endoscopy will prepare the required documentation and self certify without the need for Notified Body review.
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