Alpha Wire has received ISO 13485:2003 certification for its Carson, California, manufacturing facility. The certification encompasses the production, assembly, and quality control processes of wire and cable. ISO 13485 is the leading quality management standard for manufacturers of medical devices.
“Achieving this important ISO certification underscores Alpha Wire’s commitment to providing the highest quality wire and cable products to our customers in the medical industry,” says Mike Dugar, president of Alpha Wire. “It also demonstrates our commitment to continue helping medical device manufacturers meet increasingly stringent regulatory requirements.”
With the medical market’s trends of microminiaturization and higher performance requirements, Alpha Wire’s Coast™ Custom Cable design and manufacturing capabilities allow for smaller composite cables to be tailored to specific design requirements such as high flexibility, sterilization resistance, low noise, minimal elongation, and high tensile strength. Alpha Wire offers a wide range of medical-grade USP Class VI and FDA-approved materials to create cables specifically tailored to medical devices for diagnostic, monitoring, and treatment applications.