TUV SUD America, a testing, inspection and certification organization, has completed its stage 2 ISO 13485 audit with Solos Endoscopy on August 16, 2013.
Solos Endoscopy will be certified to ISO 13485:2003, the internationally-recognized standard for quality systems for medical device manufacturers, upon review and successful completion of the final audit.
The certification allows the company to place the CE Mark on its entire MammoView instrument line which will allow the instrument line to be sold globally.
The company expects to complete the entire process by the end of 2013 and launch its instruments internationally in 2014.
Solos Endoscopy retained Emergo Europe officially as its authorized representative in Europe.
Emergo will provide Solos assistance related to liasioning with authorities and importation of Solos instruments in Europe.
Solos Endoscopy CEO Robert Segersten said, "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."
The Solos MammoView breast endoscopy system incorporates advanced microendoscopes and optical technology to provide sharp images of the milk ducts where the majority of breast cancer arises.