Company Posts ISO 13485 Certification and CE Mark Project Schedule
BOSTON, July 25, 2012 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company now has the capability to provide 45cm instruments for use in bariatric procedures, not only in its standard line of instruments but also in the SteriTAP line. Solos endoscopic instruments range from 32 cm up to 45 cm and can be customized with a variety of handles.
In response to the industry's trend toward new procedures for the most overweight sectors of our population, Solos now offers all of its instruments in lengths from 32cm up to 45cm. Complications following surgical treatment of obese patients vary based upon the procedure performed and can be as high as 40 percent. Due to the high surgical volume, improving the safety of these operations has become a high priority, leading to the development of new instruments by Solos Endoscopy which all meet FDA guidelines for safe and effective bariatric surgery.
Solos previously announced that it has commenced its initiative to complete its ISO 13485 Certification and CE Mark initiative with Expert Resource. Expert Resource will prepare Solos Endoscopy for the final audit, 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 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.
Solos Endoscopy's instruments are FDA approved. Upon the Company's completion of its ISO 13485 Certification, the Company will be able to place the CE Mark on its entire instrument line, including its new Bariatric Instruments. Both Solos and Expert Resource believe the ISO 13485 Certification and CE Mark initiative will be completed within the next 5 months. The Company has posted the entire project schedule on its website, http://www.solosendoscopy.com/SNDY-ISO-13485-CE-Mark-Project-Schedule-July-2012.pdf.
About Expert Resource
Expert Resource is an international consulting and training firm specializing in business improvement initiatives. ER helps medical device and medical laboratory companies implement ISO 13485, ISO 15189, ISO 14971, or GMP quality systems, obtain the CE Mark, submit FDA 510(k) applications, assist with clinical trials, and more. For more information on Expert Resource, visit www.expertresource.net.
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.
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.