CYduct Diagnostics Inc (CYDX)

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( SNDY ) Solos Endoscopy Successfully Completes ISO Certification Annual Audit by TUV SUD America
22 minutes ago - DJNF
BOSTON, MA / ACCESSWIRE / October 8, 2014 / Solos Endoscopy, Inc. (OTC Pink: SNDY) (PINKSHEETS: SNDY), a provider of quality innovative healthcare instruments to hospitals across the country, is pleased to announce that the company has successfully completed the annual audit for its ISO 13485:2003 Certification from TUV SUD America. The Certification to ISO 13485:2003 allows Solos Endoscopy to place the CE Mark on the majority of the company's endoscopic instruments including the MammoView(R) devices.
The Certification Body of TUV America 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 initial Certification came at the conclusion of a lengthy audit with TUV SUD America this past year. The annual 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).

Solos Endoscopy has posted its Certificate from TUV America on its website (http://www.solosendoscopy.com)

"Solos Endoscopy has expended considerable resources to meet both the standards of the FDA and to become ISO Certified. I'm real proud of our team," stated Robert Segersten, President of Solos Endoscopy.

Solos Endoscopy has begun to expand its efforts into Canada with its filing for the Canadian Medical Device License, which will allow Solos to sell certain endoscopic instruments, including the MammoView(R) devices, in Canada. The Canadian Medical Device License (MDL) is required for manufacturers of Class II, III, and IV medical devices in Canada. Canada's MDL is comparable to the US FDA 510(k) process, except the process of securing an MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices. Health Canada's Medical Device Bureau (MDB) previously completed an initial evaluation of certain Solos Endoscopy instruments and has classified its devices as Class II medical devices.