Solos Endoscopy, Inc. Successfully Completes Phase One Requirements for ISO 13485 Quality Management System Initiative
BOSTON, April 13 /PRNewswire-FirstCall/ -- Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce that the Company has successfully completed Phase One requirements for the Company's ISO 13485 quality management system (QMS) initiative. The project is divided into four phases, each with predetermined deliverables. Compliance with ISO 13485 is a major step in obtaining the CE Mark and the permission to sell medical devices in the European Union, which represents $94 Billion, or 30%, of the worldwide demand for medical instruments, according to a 2009 Frost & Sullivan report.
Phase One in the development of the QMS included: a Kickoff Session meeting with key process owners to set the expectations of the project as well as define the roles and responsibilities of each participant; creation of the Document Map, which is a tool listing all documentation to be created relating to requirements of the standard; a Project Plan, which outlines every milestone and its scheduled start and completion dates; and finally the creation of the first eight Level Two procedures, defining the (who, what, when and where) procedures using the Document Map as an outline.
"We are pleased to have completed the first phase of such an important project and milestone for the company," stated Bob Segersten, President of Solos Endoscopy, Inc. "And we are on track with our plan for completion of the QMS initiative in the third quarter of 2010."
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.