BOSTON, June 12, 2013 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company and TUV SUD America has scheduled its Stage 2 ISO 13485 Audit for August 16, 2013.
Solos Endoscopy completed the Stage 1 Audit with TUV SUD America on Tuesday, February 26, 2013. Solos Endoscopy's Quality Manual and 28 Quality System Procedures were reviewed by TUV SUD for compliance to 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 will work with consulting company Expert Resource to correct any non-conformities found during the Stage 1 Audit in preparation for the Stage 2 Audit with TUV SUD. Solos Endoscopy has six months from the Stage 1 Audit to schedule the Stage 2 Audit. Successful completion of the Stage 2 Audit will result in Solos Endoscopy being certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003 will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the MammoView® in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView® product line in Canada.
TUV SUD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to the ISO 13485 standard. TUV SUD also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TUV SUD is a Notified Body for certification to all relevant EU Directives. With this complete service package, TUV SUD can assist medical companies in accessing markets nationally, in Europe, and globally. Solos Endoscopy has posted on its website an updated schedule as of January 2013.
Expert Resource will attend the final audit, and help interpret any findings. Solos Endoscopy joins a high profile Expert Resource client list which includes BASF, Black & Decker, Dow Precision, Hitachi, J.D. Power & Associates, Microsoft Corporation, Northrop Grumman, Quest, and Toshiba, amongst many others. According to Expert Resource, their consultants maintain a 100% success rate of passing the final audit on the first attempt. Solos Endoscopy has posted its updated ISO 13485 CE Mark Schedule on its website, http://www.solosendoscopy.com/investors.html.
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 www.tuvamerica.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.
SOURCE Solos Endoscopy, Inc.