CYduct Diagnostics Inc (CYDX)

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Solos Endoscopy has received its ISO 13485:2003 Certification from TUV SUD America. The
Certification to ISO 13485:2003 will in turn allow Solos Endoscopy to place the CE Mark on the majority of its endoscopic instruments including the MammoView® devices. The Certification Body of TUVAmerica has certified that Solos Endoscopy has established and is maintaining a quality management system that meets the requirements of the European Union and Canada. The Certification came at the conclusion of a lengthy Audit with TUV SUD America in 2013. The Audit included a comprehensive review of the Solos Endoscopy's Quality Manual and 28 Quality System Procedures for compliance with the international quality system standard ISO 13485:2003, to the European Union's Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).