BOSTON, MA -- (Marketwired) -- 01/28/14 -- Solos Endoscopy, Inc. (OTC Pink: SNDY), a provider of quality innovative healthcare instruments to hospitals across the country, is pleased to announce that the Company has received its ISO 13485:2003 Certification from TUV SUD America. The Certification to ISO 13485:2003 will in turn allow Solos Endoscopy to place the CE Mark on the majority of endoscopic instruments including the MammoView® devices.
The Certification Body of TUV America has certified that Solos Endoscopy has established and is maintaining a quality management system that meets the requirements of the European Union and Canada. The Certification comes at the conclusion of a lengthy audit with TUV SUD America this past year. The audit included a comprehensive review of Solos Endoscopy's Quality Manual and 28 Quality System Procedures for compliance with 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 has posted its Certificate from TUV America on its website, (http://www.solosendoscopy.com).
"ISO Certification is an amazing accomplishment for a company our size. I am proud to say that Solos Endoscopy now carries endoscopic instruments that are both FDA approved and ISO Certified," stated Robert Segersten, President of Solos Endoscopy.
Now that Solos Endoscopy is ISO Certified, the Company will begin to focus its sales efforts internationally. Solos Endoscopy previously retained Emergo Group as its 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 liaison 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.
About Solos Endoscopy, Inc.:
Solos Endoscopy celebrated 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. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.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.