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( SNDY ) Solos Endoscopy Files for Medical Device License to Distribute its Endoscopic Instruments in Canada
5 minutes ago - DJNF
BOSTON, MA / ACCESSWIRE / September 16, 2014 / Solos Endoscopy, Inc. (OTC PINK: SNDY) (PINKSHEETS: SNDY), a provider of quality innovative healthcare instruments to hospitals across the United States, is pleased to announce that the company has completed 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) had previously completed an initial evaluation of certain Solos Endoscopy instruments and has classified its devices as Class II medical devices.

When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality system as well as meet the specific requirements of the Canadian Medical Device Regulations (CMDR). Solos Endoscopy Instruments meet all the requirements as the company's instruments are both FDA and ISO certified.

Solos Endoscopy recently received 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 its endoscopic instruments including the MammoView(R) devices. Upon approval of the application for its Medical Device Registration in Canada, Solos Endoscopy will have the ability to offer its instruments to the multi-billion dollar Canadian market.

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 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/pdf/solos-iso-certification.pdf).

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: 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.

CONTACT:

Solos Endoscopy, Inc.

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SOURCE: Solos Endoscopy, Inc.

(END) Dow Jones Newswires

September 16, 2014 10:42 ET (14:42 GMT)