Solos Endoscopy Completes Stage 2 of its ISO 13485
Post# of 1609
Posted On: 08/22/2013 2:24:20 PM
Solos Endoscopy Completes Stage 2 of its ISO 13485 Audit with TUV SUD America
BOSTON, MA, August 22, 2013 – (Accesswire) - Solos Endoscopy, Inc. (SNDY) is pleased to announce that TUV SUD America 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, once it reviews and resolves any corrective actions that were discovered during the final audit.
Solos Endoscopy will work with TUV SUD America and Expert Resources to complete the certification to ISO 13485:2003, which will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView[R] devices to sell the MammoView[R] in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView[R] product line in Canada. The Company expects the entire process to be concluded by the end of the year, 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.
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 liason 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.
“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.
The Solos MammoView[R] Breast Endoscopy System employs advanced microendoscopes and optical technology which gives physicians sharp images of the milk ducts where the majority of breast cancer arises. Solos Endoscopy instruments are FDA approved. Upon Solos Endoscopy’s receipt of its ISO 13485 Certification, the Company will be able to place the CE Mark on its entire MammoView[R] instrument line which will allow the instrument line to be sold globally.
About Solos Endoscopy, Inc.:
Solos Endoscopy is celebrating its 25th Year of providing quality innovative healthcare instruments to Hospitals across the Country. For more than 25 Years, from medical schools to hospitals, surgeons have trusted Solos Endoscopy to develop and market breakthrough technology, applications, medical devices, and procedural techniques for the screening, diagnosis, treatment and management of disease and medical conditions.
For more information on TUV SUD America visit
BOSTON, MA, August 22, 2013 – (Accesswire) - Solos Endoscopy, Inc. (SNDY) is pleased to announce that TUV SUD America 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, once it reviews and resolves any corrective actions that were discovered during the final audit.
Solos Endoscopy will work with TUV SUD America and Expert Resources to complete the certification to ISO 13485:2003, which will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView[R] devices to sell the MammoView[R] in the European Union. ISO 13485:2003 certification is also a necessary for the company to sell the MammoView[R] product line in Canada. The Company expects the entire process to be concluded by the end of the year, 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.
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 liason 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.
“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.
The Solos MammoView[R] Breast Endoscopy System employs advanced microendoscopes and optical technology which gives physicians sharp images of the milk ducts where the majority of breast cancer arises. Solos Endoscopy instruments are FDA approved. Upon Solos Endoscopy’s receipt of its ISO 13485 Certification, the Company will be able to place the CE Mark on its entire MammoView[R] instrument line which will allow the instrument line to be sold globally.
About Solos Endoscopy, Inc.:
Solos Endoscopy is celebrating its 25th Year of providing quality innovative healthcare instruments to Hospitals across the Country. For more than 25 Years, from medical schools to hospitals, surgeons have trusted Solos Endoscopy to develop and market breakthrough technology, applications, medical devices, and procedural techniques for the screening, diagnosis, treatment and management of disease and medical conditions.
For more information on TUV SUD America visit
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