Stage 2 Audit with TÜV SÜD America Expert Resour
Post# of 1609
Posted On: 10/07/2013 9:34:48 PM
Stage 2 Audit with TÜV SÜD America Expert Resources Report
Solos Endoscopy has passed its Stage 2 audit with Notified Body and registrar TÜV SÜD for registration to ISO 13485:2003. The Stage 2 audit was conducted August 15 - 16, 2013. TÜV SÜD found no non-conformities to Solos Endoscopy's Quality Management System requirements in the audit. It was noted that documentation required for the European Union has not yet been developed and so Solos Endoscopy cannot sell its devices to the European Union at this time.
Solos Endoscopy is now in the process of drafting Technical Files and associated documents for the MammoView® devices the company intends to sell in Europe. TÜV SÜD will review the Technical Files for Solos Endoscopy's sterile devices in the MammoView® system. Since the Ductoscope is a Class I device in the European Union, Solos Endoscopy will prepare the required documentation and self certify without the need for Notified Body review.
Once the documentation has been prepared and TÜV SÜD reviews and approves the required documentation for the sterile devices, TÜV SÜD will certify Solos Endoscopy to ISO 13485:2003 and provide certificates for CE Marking for Solos Endoscopy's sterile MammoView® system devices. CE Marking will allow Solos Endoscopy to sell its MammoView® devices to the European Union.
blueskies
Solos Endoscopy has passed its Stage 2 audit with Notified Body and registrar TÜV SÜD for registration to ISO 13485:2003. The Stage 2 audit was conducted August 15 - 16, 2013. TÜV SÜD found no non-conformities to Solos Endoscopy's Quality Management System requirements in the audit. It was noted that documentation required for the European Union has not yet been developed and so Solos Endoscopy cannot sell its devices to the European Union at this time.
Solos Endoscopy is now in the process of drafting Technical Files and associated documents for the MammoView® devices the company intends to sell in Europe. TÜV SÜD will review the Technical Files for Solos Endoscopy's sterile devices in the MammoView® system. Since the Ductoscope is a Class I device in the European Union, Solos Endoscopy will prepare the required documentation and self certify without the need for Notified Body review.
Once the documentation has been prepared and TÜV SÜD reviews and approves the required documentation for the sterile devices, TÜV SÜD will certify Solos Endoscopy to ISO 13485:2003 and provide certificates for CE Marking for Solos Endoscopy's sterile MammoView® system devices. CE Marking will allow Solos Endoscopy to sell its MammoView® devices to the European Union.
blueskies
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