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Solos Endoscopy and TUV SUD America Schedule Stage 2 ISO 13485 Audit for August 16, 2013
Date:6/12/2013

BOSTON, June 12, 2013 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company and TUV SUD America has scheduled its Stage 2 ISO 13485 Audit for August 16, 2013.

Solos Endoscopy completed the Stage 1 Audit with TUV SUD America on Tuesday, February 26, 2013. Solos Endoscopy's Quality Manual and 28 Quality System Procedures were reviewed by TUV SUD for compliance to the international quality system standard ISO 13485:2003, to the European Union's Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).

Solos Endoscopy will work with consulting company Expert Resource to correct any non-conformities found during the Stage 1 Audit in preparation for the Stage 2 Audit with TUV SUD. Solos Endoscopy has six months from the Stage 1 Audit to schedule the Stage 2 Audit. Successful completion of the Stage 2 Audit will result in Solos Endoscopy being certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003 will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the MammoView® in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView® product line in Canada.

TUV SUD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to the ISO 13485 standard. TUV SUD also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TUV SUD is a Notified Body for certification to all relevant EU Directives. With this complete service package, TUV SUD can assist medical companies in accessing markets nationally, in Europe, and
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SOURCE Solos Endoscopy, Inc.
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