Exact Imaging, a developer in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced that its quality management system has been certified as complying with the requirements of ISO 13485:2003 and EN ISO 13485:2012.
The standard represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
“Obtaining the ISO 13485 certification is an important validation of Exact Imaging’s comprehensive Quality System and our dedicated, customer-focused team,” said Randy AuCoin, president and CEO of Exact Imaging. “This certification is also a key step in the company’s short-term plans to launch and support our ExactVu platform, pending regulatory approvals, to the global urology marketplace in the coming months.”
Earning the ISO 13485 certificates demonstrates Exact Imaging’s continued commitment to provide clinical imaging products that consistently exceed the requirements of their customers as well as meet the North American and international medical device industry compliance requirements.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements across the multiple stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and provision of technical support activities.