Solos Endoscopy, Inc. to Finalize ISO 13485 Certification and CE Mark Initiative with Expert Resource for Endoscopic Instruments
Solos previously retained Expert Resource and completed Phase I of IV of its requirements for its ISO 13485 QMS initiative. Solos had to temporarily suspend its efforts due to unanticipated increased costs, partially attributable to changes in documentation required by the International Organization for Standardization (ISO); as a result, the Company exceeded its maximum budgetary constraints. However currently, Solos has been able to utilize its equity, increase its authorized capital, and has made all the necessary financial arrangements to complete the certification. All Solos Endoscopy instruments are FDA approved, but with ISO 13485 Certification they will also all receive the CE Mark required for international sales.
Expert Resource will provide comprehensive consulting, training and document preparation for Solos Endoscopy to create a quality management system that meets the requirements of the ISO 13485 standard. Compliance with ISO 13485 is a major step in obtaining the CE Mark and the permission to sell medical devices in Europe and Canada.
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.
According to Reportlinker, the demand for endoscope services is increasing due to an increase in the aging and chronically ill population worldwide. Advancements in endoscopic technologies and inclusion of various types of lighting sources, video cameras, real-time conversion of data into three-dimensional images are also driving this market. Endoscopy procedures have become highly effective in the diagnosis, treatment, and management of cancer patients. Many now consider endoscopy to have become the gold standard for cancer diagnosis and treatment, as well as for many other medical conditions.
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.
CONTACT:
AMANDA SEGERSTEN
RSEGERSTEN@SOLOSENDOSCOPY.COM
SOURCE Solos Endoscopy, Inc.