Resources: Press Room

Certifications

Jun 24, 2013 —

New Certifications Further Expand IZI Products in Global Markets

IZI Medical Products successfully completed an extensive audit to receive certification for ISO 13485:2003, Canadian Medical Device Regulations (CMDR), and the European Medical Device Directive (MDD 93/42/EEC). The audit was conducted by TœV America. In January 2006, we learned that our recommendation to receive these certifications was accepted. These certifications will allow IZI to grow its position in the global economy's medical product arena. Certification is granted to companies whose quality systems and procedures meet or exceed those mandated by regulatory requirements. IZI's ability to withstand the scrutiny of an international audience validates our best practices and demonstrates the strength of our business model.



These three distinct certifications of IZI's quality management system are critical to IZI's efforts to market and export products to the global market. Obtaining ISO 13485:2003 certification is a clear demonstration of IZI's commitment to provide the safest, highest quality products to their customers, as well as superior customer service.

To be recommended for the prestigious ISO certification, a company must develop and implement a quality system that encompasses every aspect of the business, from purchasing and customer service, to product safety and inspection regulations. This international quality standard is specific to companies producing medical devices, and includes additional requirements over and above the ISO 9001 standard. These additional requirements relate to design controls, process controls, traceability, record retention, and regulatory actions - all critical for the medical device industry.

In addition to IZI's ISO certification, the company is pleased to announce that its compliance to the European Medical Devices Directive will permit IZI to add the "CE" mark to its devices, thus allowing the free trade of products throughout countries of the European Union, while our certification of conformance to the Canadian Medical Device Regulations will open the Canadian market. In this way, IZI is making strides toward bringing quality products to a global community and becoming a small company that is a worldwide contender in the competitive medical accessory industry.