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Thursday, August 22, 2013 10:57:50 AM
Congratulation SNDY!!
A few important points:
...Solos Endoscopy will be certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers
...which will allow the Company to market and sell its instruments internationally in 2014.
...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.
..."We would like to thank TUV SUD America and Expert Resources for their continued support as we accomplish our goal to market Solos instruments worldwide," stated Robert Segersten, Solos Endoscopy, CEO.
...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 consultants will assist Solos with a wide variety of regulatory, quality assurance, and distribution.
blueskies
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