Solos Endoscopy Successfully Completes ISO Certification Annual Audit by TUV SUD America

BOSTON, MA / ACCESSWIRE / October 8, 2014 / Solos Endoscopy, Inc. (OTC Pink: SNDY) SNDY, a provider of quality innovative healthcare instruments to hospitals across the country, is pleased to announce that the company has successfully completed the annual audit for its ISO 13485:2003 Certification from TUV SUD America. The Certification to ISO 13485:2003 allows Solos Endoscopy to place the CE Mark on the majority of the company's endoscopic instruments including the MammoView(R) 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 initial Certification came at the conclusion of a lengthy audit with TUV SUD America this past year. The annual audit included a comprehensive review of the 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/)

"Solos Endoscopy has expended considerable resources to meet both the standards of the FDA and to become ISO Certified. I'm real proud of our team," stated Robert Segersten, President of Solos Endoscopy.

Solos Endoscopy has begun to expand its efforts into Canada with its filing for the Canadian Medical Device License, which will allow Solos to sell certain endoscopic instruments, including the MammoView(R) devices, in Canada. The Canadian Medical Device License (MDL) is required for manufacturers of Class II, III, and IV medical devices in Canada. Canada's MDL is comparable to the US FDA 510(k) process, except the process of securing an MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices. Health Canada's Medical Device Bureau (MDB) previously completed an initial evaluation of certain Solos Endoscopy instruments and has classified its devices as Class II medical devices.

About Solos Endoscopy, Inc.:

Solos Endoscopy has 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: http://www.solosendoscopy.com/.

Forward-Looking Statements

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.

CONTACT:

Solos Endoscopy, Inc.

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SOURCE: Solos Endoscopy, Inc.