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Norman Noble achieved ISO 13485:2016 registration for its Quality Management System (QMS) following a full recertification audit by the British Standards Institute (BSI). ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry.
ISO 13485:2016 registration demonstrates Norman Noble’s continued commitment to the highest level of medical device product quality and regulatory compliance. ISO 13485-registered since 2004, this update supports our customers’ efforts to maintain compliance with the latest domestic (FDA) and international (MDSAP and European MDR) regulatory requirements.Â
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