Solos Endoscopy, Inc. 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.
"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.
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 .
