Vexim, the specialist in medical devices for the minimally invasive, anatomical treatment of vertebral compression fractures (VCF), today announced that it has obtained CAN/CSA ISO 13485:2003 certification in Canada. This certification guarantees the SpineJack® solution's compliance with the Canadian regulatory quality system requirements for medical devices and paves the way for its commercialization in Canada, which Vexim currently plans to implement via a distributor.
"Here at Vexim, we pay a great deal of attention to the product risk management process, in order to ensure optimal safety and quality. We are delighted to have obtained this certification, which emphasizes our absolute requirement for quality and compliance with international standards and will significantly contribute to our project to commercialize the SpineJack® on the Canadian market in the near future", commented Vexim's President and CEO Bruce de la Grange.
The CAN/CSA ISO 13485:2003 certification was awarded by DEKRA Certification BV, a Netherlands-based, Canadian recognized notified body. In view of the CE marking of the company's products (obtained in 2008 and 2009), Vexim's production and quality managers perform annual exhaustive audits to ensure that all of its subcontractors comply with international quality standards such as ISO 9001 and ISO 13485.
Medical grade adhesives for medical device manufacturing