Michael Barbella, Managing Editor06.28.22
Norman Noble Inc. has achieved ISO 13485:2016 registration for its Quality Management System (QMS) following a full 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.
Established more than 75 years ago, Norman Noble Inc. is a family-owned and -operated company offering advanced processes for ultra-precision micromachining of medical implants. The company is known for its ability to produce nitinol-based implants and to achieve subminiature precision beyond the reach of most manufacturers. Norman Noble supplies most of the largest OEMs and well-known names in the medical device industry. Norman Noble manufactures medical devices and implants to customer specifications in compliance with U.S. Food and Drug Administration regulations and ISO 13485. State-of-the-art processes include athermal laser machining, laser welding, Swiss turning and milling, conventional and wire EDM, high-speed seven-axis contour milling, electropolishing, nitinol shape setting, and clean room assembly and packaging. Rapid development prototyping services are available in separate and fully dedicated process development centers.
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.
Established more than 75 years ago, Norman Noble Inc. is a family-owned and -operated company offering advanced processes for ultra-precision micromachining of medical implants. The company is known for its ability to produce nitinol-based implants and to achieve subminiature precision beyond the reach of most manufacturers. Norman Noble supplies most of the largest OEMs and well-known names in the medical device industry. Norman Noble manufactures medical devices and implants to customer specifications in compliance with U.S. Food and Drug Administration regulations and ISO 13485. State-of-the-art processes include athermal laser machining, laser welding, Swiss turning and milling, conventional and wire EDM, high-speed seven-axis contour milling, electropolishing, nitinol shape setting, and clean room assembly and packaging. Rapid development prototyping services are available in separate and fully dedicated process development centers.