Bi-Link nets ISO certification in U.S., Mexico and China
BLOOMINGDALE -- Global contract manufacturer Bi-Link said its Bloomingdale and Juarez facilities have been recommended for ISO 13485:2003 certification.
Joining Bi-Link's China manufacturing facility in Shanghai, the 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 health care 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, Bi-Link medical segment marketing manager. "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 life cycle cost and accelerates time to market by helping engineers validate designs based on solid DFM principles and rapid "pre-prototypes."