BOSTON, MA, August 22, 2013 – Solos Endoscopy, Inc. (OTCPink: SNDY) is pleased to announce that TUV SUD America has completed its Stage 2 ISO 13485 Audit with Solos Endoscopy on August 16, 2013. Solos Endoscopy will be certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers, once it reviews and resolves any corrective actions that were discovered during the final audit.
Solos Endoscopy will work with TUV SUD America and Expert Resources to complete the certification to ISO 13485:2003, which will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView[R] devices to sell the MammoView[R] in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView[R] product line in Canada. The Company expects the entire process to be concluded by the end of the year, which will allow the Company to market and sell its instruments internationally in 2014.
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.
“We would like to thank TUV SUD America and Expert Resources for their continued support as we accomplish our goal to market Solos instruments worldwide,” stated Robert Segersten, Solos Endoscopy, CEO.
The Solos MammoView[R] 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. 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[R] 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 TUV SUD America visit http://www.tuvamerica.com/. For more information on Emergo Group visit http://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 http://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.
SOURCE Solos Endoscopy, Inc.