Solos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit With TUV SUD America
09 October 2013 - 12:00AM
Marketwired
Solos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit
With TUV SUD America
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.
Once the documentation has been prepared and TÜV SÜD reviews and
approves the required documentation for the sterile devices, TÜV
SÜD will certify Solos Endoscopy to ISO 13485:2003 and provide
certificates for CE Marking for Solos Endoscopy's sterile
MammoView® system devices. CE Marking will allow Solos
Endoscopy to sell its endoscopic instruments, including the
MammoView® devices to the European Union. The Company expects the
entire process to be concluded by the end of the year. Solos
Endoscopy plans to market and sell its instruments
internationally in 2014.
"Solos Endoscopy is committed
to the worldwide distribution of its endoscopic instruments. We
believe this dedication will result in increased sales and profits
for the Company and its shareholders," stated Robert Segersten,
Solos Endoscopy, CEO.
Solos Endoscopy retained
Emergo Europe to act as the official Authorized Representative in
Europe. Emergo will provide Solos assistance related to
communications with authorities and importation of Solos
instruments in Europe. Emergo Group will register Solos instruments
with the Competent Authorities (Ministry of Health) as required,
including the Dutch Ministry of Health. Emergo will act as a liason
for Solos Endoscopy between the European Commission and national
Competent Authorities. Emergo Europe consultants will assist Solos
with a wide variety of regulatory, quality assurance, and
distribution.
The Solos MammoView® Breast
Endoscopy System employs advanced microendoscopes and optical
technology which gives physicians sharp images of the milk ducts
where the majority of breast cancer arises. This allows physicians
to detect breast cancer significantly faster than the traditional
mammography. Solos Endoscopy instruments are FDA
approved. Upon Solos Endoscopy's receipt of its ISO 13485
Certification, the Company will be able to place the CE Mark on its
entire MammoView® instrument line which will allow the instrument
line to be sold globally.
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 TÜV
SÜD America visit www.tuvamerica.com. For more information on
Emergo Group visit www.emergogroup.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.
Solos Endoscopy, Inc. Investor Relations (617) 360-9719