Bi-Link, a global contract manufacturer headquartered in Bloomingdale, Illinois, announced that its Bloomingdale and Juarez facilities have been recommended for ISO 13485:2003 certification.
Joining Bi-Link’s China manufacturing facility in Shanghai, this certification of compliance recognizes Bi-Link’s policies, practices and procedures are able to consistently meet customer and regulatory requirements for medical device manufacturing and other related services.
“Although Bi-Link has been serving the healthcare and medical device industries for over a decade, certification of its North American manufacturing facilities demonstrates Bi-Link’s dedication to delivering a consistent level of quality, efficiency and responsiveness across the globe,” said Terri Marion, medical segment marketing manager at Bi-Link. “Many of our current customers are global, industry-leading OEMs who must meet increasingly strict technical, functional and regulatory requirements. Being ISO 13485-certified ensures our customers that we are committed to supporting them and their needs.”
Bi-Link has over 50 years of experience helping product engineers solve complex design challenges with a process called “Mind to Market.” This vertically integrated process lowers overall lifecycle cost and accelerates time to market by helping engineers validate designs based on solid DFM principles and rapid “pre-prototypes.”