Fort Wayne Metals Adds ISO 13485 Certification

Etablishes a quality-management system for contract manufacturing of round wire and cable components, assemblies, extrusion coating and other components.

Fort Wayne Metals Research Products Corp of Fort Wayne, IN, announces its recent recognition as an ISO 13485 certified contract manufacturer of medical device components. This latest certification is in addition to its long-time FDA and ISO 9001 registrations. 

“This certification gives our customers additional assurance of our quality system,” explains John Arnold, director of quality for Fort Wayne Metals. “When our Custom Assembly Division manufactures critical components for implantable and non-implantable medical devices from our wire, strands, cable and composite materials, our customers know that these components will meet their expectations for medical device quality.” 

Fort Wayne Metals’ Custom Assembly Division provides a wide range of contract manufacturing services, including swaging, welding, crimping, ECG cutting, coating and laser ablation. The ISO 13485 certification assures a consistently high level of quality for all parts. The certification is based on ISO 9001 and specifies additional quality management system requirements applicable to regulated medical device manufacturers and their suppliers. 

About Fort Wayne Metals
Fort Wayne Metals Research Products Corporation is a leading manufacturer of high-quality precision wire, strands and cables, and component assemblies for medical devices and other demanding applications. Fort Wayne Metals is an ISO 9001, ISO 13485 and AS 9100 registered company. Learn more at www.fwmetals.com.