Bolstering its healthcare credentials, Canon U.S.A., Inc., a leader in digital imaging solutions, is proud to announce that the quality management system of Virtual Imaging, Inc., has been registered by Intertek Testing Services NA, Inc., a Medical Device Single Audit Program ("MDSAP") recognized auditing organization, as conforming to the requirements of ISO 13485:2003 for the design, manufacture, installation and service of digital radiographic x-ray systems.
In order to receive ISO 13485:2003 certification, an entity must demonstrate to an authorized third party that it meets the ISO requirements for a comprehensive quality management system for the design and manufacture of medical devices. Among the activities examined as part of the audit are design and development procedures, manufacturing of components, packaging, installation and service procedures, advisory notices or recalls and adverse event reporting.
MDSAP was developed, among other reasons, to enable appropriate regulatory oversight of an entity's quality management system while minimizing the burden on industry. MDSAP allows a single audit of an entity's quality management system by an MDSAP recognized auditor, such as Intertek, to satisfy the relevant regulatory requirements of the U.S. Food and Drug Administration, as well as the requirements of the relevant regulatory authorities in Australia, Brazil, Canada, and Japan, which are the other countries that participate in MDSAP. Virtual Imaging's certification only includes the U.S. and Canada.
"Canon U.S.A. and Virtual Imaging are committed to the healthcare market and consistently strive to exceed expectations, which we hope to show with Virtual Imaging's ISO 13485:2003 certification," said Tsuneo Imai, vice president and general manager, Healthcare Solutions Division, Business Imaging Solutions Group, Canon U.S.A., Inc. and president, Virtual Imaging, Inc. "This certification indicates Virtual Imaging's commitment to compliance with applicable quality management system requirements. Virtual Imaging takes pride in its ability to provide devices for its customers to help them meet the needs of their patients and to help provide a positive diagnostic imaging experience for all parties."
For more information about radiography solutions from Virtual Imaging, please visit https://www.usa.canon.com/dr.