"We continually seek opportunities to improve our products and processes to exceed our customers’ demands for high quality medical connectors," states Gary Rychley, president of Colder Products Company. "ISO 13485 certification reinforces our commitment to the medical device market and to partnering with manufacturers to rapidly deliver new devices to market."
Globally, there is an intensifying effort to harmonize the quality systems of medical device manufacturers, and ISO 13485 has been selected as the foundation for quality system compliance. ISO 13485 is a certification specifying international requirements on the ability to continuously provide medical devices and related services to meet regulatory and customer requirements. ISO 13485 certified suppliers can help medical device manufacturers get their devices approved and into production more rapidly.