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 globally. Solos Endoscopy has
posted on its website an updated schedule as of January
2013.
Expert Resource will attend the final audit, and help interpret
any findings. Solos Endoscopy joins a high profile Expert
Resource client list which includes BASF, Black & Decker, Dow
Precision, Hitachi, J.D. Power & Associates, Microsoft
Corporation, Northrop Grumman, Quest, and Toshiba, amongst many
others. According to Expert Resource, their consultants maintain a
100% success rate of passing the final audit on the first attempt.
Solos Endoscopy has posted its updated ISO 13485 CE Mark Schedule
on its website, http://www.solosendoscopy.com/investors.html.
About Solos Endoscopy, Inc.:
Solos Endoscopy is celebrating its 25th Year of
providing quality innovative healthcare instruments to Hospitals
across the Country. For more than 25 Years, from medical schools to
hospitals, surgeons have trusted Solos Endoscopy to develop and
market breakthrough technology, applications, medical devices, and
procedural techniques for the screening, diagnosis, treatment and
management of disease and medical conditions.
For more information on TUV SUD America visit
www.tuvamerica.com.
Certain statements in this news release may contain
forward-looking information within the meaning of Rule 175 under
the Securities Act of 1933 and Rule 3b-6 under the Securities
Exchange Act of 1934, and are subject to the safe harbor created by
those rules. All statements, other than statements of fact,
included in this release, including, without limitation, statements
regarding potential future plans and objectives of the company, are
forward-looking statements that involve risks and uncertainties.
There can be no assurance that such statements will prove to be
accurate and actual results and future events could differ
materially from those anticipated in such statements. Technical
complications that may arise could prevent the prompt
implementation of any strategically significant plan(s) outlined
above. The company cautions that these forward-looking statements
are further qualified by other factors including, but not limited
to, those set forth in the company's Annual Report filing and other
filings with the OTC Markets Group (available at
www.otcmarkets.com). The company undertakes no obligation to
publicly update or revise any statements in this release, whether
as a result of new information, future events, or otherwise.
Investor Relations
(617) 360-9719
SOURCE Solos Endoscopy, Inc.