Bruin Biometrics, LLC (“BBI”) an innovative medical device manufacturer, announced today that it has received ISO 13485:2003 and EN ISO 13485:2012 certification, including CMDCAS certification, for its Quality Management System with its notified body SGS. Receipt of ISO 13485 certification demonstrates BBI’s commitment to quality in the design, development, manufacture, and distribution of non-invasive diagnostic medical devices. The ISO standard also assures BBI partners and customers that its products and processes conform to international quality standards.
“Achieving ISO 13485 certification is a substantial milestone for BBI. It demonstrates BBI’s continued commitment to the highest level of quality management and service, and to ensure distribution of safe and effective medical devices,” said Armin Beck, Vice President of QA/RA/CA & commercial operation for BBI.
BBI is privately-held and based in Los Angeles, California. For additional information, please visit www.bruinbiometrics.com.