BOSTON, March 2 Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce the Company has signed an agreement with Expert Resource (ER) to provide consulting services in support of the Company's CE Mark Technical File development. Before Solos can place the CE Marking on their medical devices and legally sell within the European Union (EU) and Canada, the Company must prepare a Technical File with evidence of compliance to the EU Medical Device Directive. ER's services, in cooperation with Solos, include the verification of the essential requirements and a risk assessment according to ISO 14971 (Risk Management). According to a 2009 report published by Frost & Sullivan, the EU represents $94 Billion, or 30%, of the worldwide demand for medical instruments.
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.
"Expanding into the EU and Canada presents enormous sales opportunities for Solos Endoscopy. We are pleased to be working with Expert Resource to provide the specialized assistance we need in obtaining the CE Mark for our medical devices," stated Bob Segersten, President of Solos Endoscopy, Inc.
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.