Solos Endoscopy Receives ISO 13485:2003 Certification

Solos Endoscopy Inc., a Boston, Mass.-based provider of healthcare instruments to U.S. hospitals, has achieved ISO 13485:2003 certification from TUV SUD America.

The certification to ISO 13485:2003 will allow Solos Endoscopy to place the CE Mark on the majority of endoscopic instruments, including the MammoView devices.

The Certification Body of TUV America has certified that Solos Endoscopy has established and is maintaining a quality management system that meets the requirements of the EU and Canada. The certification comes at the conclusion of a lengthy audit with TUV SUD America over the last year.

The audit included a comprehensive review of Solos Endoscopy’s Quality Manual and 28 Quality System procedures for compliance with the international quality system standard ISO 13485:2003, to the EU’s Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).

With its certification, the company will begin to focus its sales efforts internationally. Solos Endoscopy previously retained Emergo Group as its authorized representative in Europe.

Emergo will provide Solos assistance related to communications with authorities and importation of Solos instruments in Europe. Emergo Group also will register Solos instruments with the competent authorities (Ministry of Health) as required, including the Dutch Ministry of Health.

In addition, Emergo will act as a liaison for Solos Endoscopy between the European Commission and national competent authorities.

Solos Endoscopy was formed in 1989.