Canadian microultrasound technology developer Exact Imaging has been certified as complying with the requirements of ISO 13485:2003 and EN ISO 13485:2012 for its quality management system.
The standard represents the requirements for a quality management system for the design and manufacture of medical devices, the firm said. Specifically, it addresses whether an organization has demonstrated its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements across multiple stages -- including design and development, production, storage and distribution, installation, and servicing.
The certification is also a key step in the company's short-term plans to launch and support its ExactVu platform, pending regulatory approvals in the coming months, Exact Imaging said.
