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Solos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit With TUV SUD America
Solos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit With TUV SUD America.
About this update from Cyduct Diagnostics Inc.
[{"type":"text","content":"\n \n \n Solos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit With TUV SUD America\n \n \nSolos Endoscopy Reports Results From Stage 2 of Its ISO 13485 Audit With TUV SUD America\n \n BOSTON, MA--(Marketwired - Oct 17, 2013) - Solos Endoscopy, Inc. (OTC Pink: SNDY) is pleased to announce that the Company has passed its Stage 2 audit with Notified Body and registrar T?V S?D for registration to ISO 13485:2003. The Stage 2 audit was conducted August 15 - 16, 2013.?T?V S?D found no non-conformities to Solos Endoscopy's Quality Management System requirements in the audit.\n Solos Endoscopy is now in the process of drafting Technical Files and associated documents for the MammoView? devices the company intends to sell in Europe.?T?V S?D will review the Technical Files for Solos Endoscopy's sterile devices in the MammoView? system.?Since the Ductoscope is a Class I device in the European Union, Solos Endoscopy will prepare the required documentation and self certify without the need for Notified Body review.\n Once the documentation has been prepared and T?V S?D reviews and approves the required documentation for the sterile devices, T?V S?D will certify Solos Endoscopy to ISO 13485:2003 and provide certificates for CE Marking for Solos Endoscopy's sterile MammoView? system devices.?CE Marking will allow Solos Endoscopy to sell its endoscopic instruments, including the MammoView? devices to the European Union. The Company expects the entire process to be concluded by the end of the year. Solos Endoscopy plans?to market and sell its instruments internationally in 2014.\n \n \"Solos Endoscopy is committed to the worldwide distribution of its endoscopic instruments. We believe this dedication will result in increased sales and profits for the Company and its shareholders,\" stated Robert Segersten, Solos Endoscopy CEO.\n Solos Endoscopy retained Emergo Europe to act as the official Authorized Representative in Europe. Emergo will provide Solos assistance related to communications with authorities and importation of Solos instruments in Europe. Emergo Group will register Solos instruments with the Competent Authorities (Ministry of Health) as required, including the Dutch Ministry of Health. Emergo will act as a liaison for Solos Endoscopy between the European Commission and national Competent Authorities. Emergo Europe cons...