San Jose, Calif.-based Sanmina-SCI Corp.’s Monterrey, Mexico, facility has achieved ISO 13485 certification for medical device manufacturing. The company manufactures optical, electronic and mechanical products.

ISO 13485 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet government regulations. In order to obtain the certification, Sanmina-SCI's Monterrey facility demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical device manufacturing and related services.

"Receiving ISO 13485 certification in Monterrey opens new opportunities for customers looking for quality medical product production in North America," said Alex Scroppo, senior vice president of Sanmina-SCI's Backplane and Cable Division. "Our facility joins Sanmina-SCI's network of global facilities in providing the unique technology and complex manufacturing capabilities required in many sectors of healthcare, from medical devices and disposables to very large diagnostic imaging systems."

At this point, achieving ISO certification is old hat for Sanmina. The Monterrey facility is the company’s 21st plant to achieve ISO 13485 certification. According to the company, it has more ISO 13485 qualified facilities than any other electronics manufacturing services (EMS) provider, as well as nine U.S. Food and Drug Administration-registered factories. Sanmina has the capability to design, engineer, manufacture, and provide reverse logistics support for technologically advanced medical products.

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