Solos Endoscopy, a provider of healthcare instruments to hospitals across the US, announce that the company has received its ISO 13485:2003 Certification from TUV SUD America.
The certification to ISO 13485:2003 will in turn 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 this past 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).
Solos Endoscopy president Robert Segersten noted ISO certification is an amazing accomplishment for a company its size.
"I am proud to say that Solos Endoscopy now carries endoscopic instruments that are both FDA approved and ISO Certified," Segersten added.
Now that Solos Endoscopy is ISO Certified, 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 will register Solos instruments with the competent authorities (Ministry of Health) as required, including the Dutch Ministry of Health.
Emergo will act as a liaison 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.