TORONTO, ON-- (October 31, 2016) Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today 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,” says 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.
Exact Imaging (www.exactimaging.com) is the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Operating up to 29 MHz, the ExactVu™ micro-ultrasound platform enables a whole new level of resolution and with the benefits of ease of use, affordability, and being an extension of the current urological workflow. Using the Exact Imaging platform, urologists will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic, trans-rectal, ultrasound biopsy protocols. ExactVu™ micro-ultrasound system has CE marking (Certificate #649960) for sale in the European Union. The product is not yet commercially available in the US and Canada.
