Norman Noble

Norman Noble renews ISO 13485:2016 certification

The company is known for its ability to produce nitinol-based implants and achieving sub-miniature precision.


Norman Noble Inc., a leading contract manufacturer of next-generation medical implants, has achieved ISO 13485:2016 registration for its Quality Management System (QMS) following a recertification audit by the British Standards Institute (BSI), a European Union Notified Body.

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.