Bi-Link announces ISO 13485 certification in the U.S., Mexico and China

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 of 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.”

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