Solos Endoscopy, a provider of quality innovative healthcare instruments to hospitals across the US, is pleased to announce that the company has commenced negotiations with a Canadian distributor to sell its endoscopic instruments including the MammoView devices in Canada.
Canada’s medical device market tops $6 Billion in annual revenues, with 80% of the market concentrated in Ontario and Quebec.
"The close proximity of this large medical device market to our home office in Boston makes Canada a logical choice for our first international market since becoming ISO Certified. We plan to conclude our negotiations with our new distributor in the next few weeks," stated Robert Segersten President of Solos Endoscopy.
Solos Endoscopy recently received its ISO 13485:2003 Certification from TUV SUD America.
The Certification to ISO 13485:2003 allows Solos Endoscopy to place the CE Mark on the majority of endoscopic instruments including the MammoView devices.
After consultation with its new distributor, Solos Endoscopy will apply for its Medical Device License in Canada, which will allow the company to market its instruments in the Canadian market.
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 European Union 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 the Solos Endoscopy’s Quality Manual and 28 Quality System Procedures for compliance with the international quality system standard ISO 13485:2003, to the European Union’s Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).