Solos Endoscopy Reports Significant Progress on ISO 13485 Certification and Audit
BOSTON, October 10, 2012 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company has made significant progress in its efforts to complete its ISO 13485 Certification and Audit.
In his most recent “President’s Letter”, Solos Endoscopy President, Robert Segersten, reported that “To date, our team has been working diligently with Expert Resources and has completed, or is in the process of completing several of the requirements necessary to complete the Audit.”
Solos Endoscopy retained TÜV SÜD America, Inc. to complete its ISO 13485 Certification and Audit. The Company previously engaged Expert Resource to prepare the Company for the final audit, which will be conducted by TÜV SÜD America. Expert Resource will attend the final audit, and help interpret any findings. 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://solosendoscopy.com/pdf/SNDY-ISO-13485-CE-Mark-Project-Schedule-October-2012.pdf.
TÜV SÜD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to the ISO 13485 standard. TÜV SÜD also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TÜV SÜD is a Notified Body for certification to all relevant EU Directives. With this complete service package, TÜV SÜD can assist medical companies in accessing markets nationally, in Europe, and globally.
Solos Endoscopy’s President’s Letter and CE Mark Schedule are posted on its website www.solosendoscopy.com. The Company is in the process of completing its 3rd Quarter Financial statement, which will be posted on OTC Markets within the next several weeks.
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
For more information on TÜV SÜD America visit www.tuvamerica.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
Source: Solos Endoscopy, Inc.
Contact: (617) 360-9719