BOSTON, Aug. 21, 2012 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company has retained TUV SUD America, Inc. to complete its ISO 13485 Certification and Audit.
Solos Endoscopy previously engaged Expert Resource to prepare the Company for the final audit, which will be conducted by TUV SUD 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.
TUV SUD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to the ISO 13485 standard. TUV SUD also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TUV SUD is a Notified Body for certification to all relevant EU Directives. With this complete service package, TUV SUD can assist medical companies in accessing markets nationally, in Europe, and globally.
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 instruments are FDA approved. Upon Solos Endoscopy’s receipt of its ISO 13485 Certification, the Company will be able to place the CE Mark on its entire instrument line. Both Solos and Expert Resource believe the ISO 13485 Certification and CE Mark initiative will be completed within the next 5 months.
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.
For more information on TUV SUD 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.
Contact info:
Amanda Segersten
asegersten@solosendoscopy.com
SOURCE Solos Endoscopy, Inc.
