Bruin Biometrics, a privately-held medical device manufacturer, has announced 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.
Bruin Biometrics QA/RA/CA and commercial operation vice president Armin Beck noted achieving ISO 13485 certification is a substantial milestone for the company.
"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," Beck added.