key word is.....
COMPLETED
Solos Endoscopy completed the Stage 1 Audit with TUV SUD America on Tuesday, February 26, 2013. Solos Endoscopy's Quality Manual and 28 Quality System Procedures were reviewed by TUV SUD for compliance to 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).
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Solos Endoscopy and TÜV SÜD America has scheduled its Stage 2 ISO 13485 Audit to be completed on
August 16, 2013. Upon successful completion of the Stage 2 Audit, including a review of the Auditor’s report
and resolution to any corrective actions, Solos will be certified to ISO 13485:2003, the internationally
recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003
will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the
MammoView® in the European Union. According to a 2009 report published by Frost & Sullivan, the
European Union represents $94 Billion, or 30%, of the worldwide demand for medical instruments. ISO
13485:2003 certification is also necessary for the company to sell the MammoView® product line in
Canada. Recently, as part of the process to obtain the CE Mark, Solos Endoscopy has retained Emergo
Group to act as the Company's authorized representative in Europe. Emergo Group will provide Solos
assistance related to communications with authorities and importation of Solos instruments into Europe.
The company previously was successful in completing the Food and Drug Administration (FDA) Level II
Baseline Inspection in which it received a NAI (No Action Indicated) for the inspection. It is standard for the
FDA to perform unannounced inspections periodically for medical device manufacturers, and the
successful inspection by the FDA validates the Company's quality system and its strict adherence to that
system.
Solos has several exciting new advances in product development that will change the way minimally
invasive procedures are utilized in the medical field in order to treat and prevent disease. These products
will allow the physician to examine organs and tissues within the body without the need for intrusive surgery.
The Company is currently marketing its next generation breast endoscopy system, the MammoView®
system, for early breast cancer detection.
Solos Endoscopy’s core business is the development and marketing of medical technology, applications,
medical devices and procedural techniques for the screening, diagnosis, treatment and management of
disease and medical conditions.
SNDY WILL CHANGE MANY LIVES!!!
blueskies
