US-based Solos Endoscopy has successfully passed Stage 2 of ISO 13485:2003 audit with TUV SUD America.
TUV SUD conducted Stage 2 audit for registration to ISO 13485:2003 from 15 August to 16 August 2013 and found no non-conformities to Solos Endoscopy’s quality management system requirements in the audit.
With this positive outcome from TUV SUD, Solos Endoscopy is now in the process of drafting technical files and associated documents for the MammoView devices which the company plans to sell in Europe.
The technical files for the company’s sterile devices in the MammoView system will be reviewed by TUV SUD.
TUV SUD will certify Solos Endoscopy to ISO 13485:2003 and provide certificates for CE marking for the company’s sterile MammoView system devices after reviewing and approving the company’s documentation.
The company can sell its endoscopic instruments, including the MammoView devices, in the EU after obtaining the CE mark.
Solos Endoscopy anticipates the completion of the entire process by the end of 2013 and plans to sell its devices globally in 2014.
The company will prepare the required documentation for its ductoscope and self certify the device without the need for TUV SUD review as it is a Class I device in the EU.