Sanmina-SCI's Lod, Israel, facility has received ISO 13485:2003 certification to manufacture prototypes, printed circuit board assemblies (PCBAs), electro-mechanical assemblies, subsystems and systems for electrical medical devices.
In order to obtain the certification, Sanmina-SCI had demonstrated the ability to consistently meet strict requirements for Quality Management Systems (QMS) applicable to medical device manufacturing and related services.
Gelston Howell, senior vice president of medical division at Sanmina-SCI, said: “Earning the ISO 13485:2003 certification represents a significant accomplishment for the Lod, Israel, facility as it emphasizes Sanmina-SCI’s commitment to meeting the highest standards of quality required by its medical customers.
“Our ability to support medical customers in Lod, Israel, complements Sanmina-SCI’s global strategy, and reinforces our growth and leadership position for this key market segment. We have an excellent global network of 14 ISO 13485:2003 certified facilities that include Lod and Ma’alot, Israel.
“These facilities are also FDA registered and/or QSR compliant ensuring that Sanmina-SCI meets the stringent requirements of the medical industry.”
Samuel Semel, general manager and managing director for Israel at Sanmina-SCI, said: “Receiving the ISO 13485:2003 certification clearly demonstrates Sanmina-SCI’s dedication to offer worldwide manufacturing locations to its medical customers. This key certification opens new opportunities for medical device manufacturing to our customers who are looking for lower-cost and quality solutions in this region.”
Sanmina-SCI’s medical division offers medical device original equipment manufacturers (OEMs) complete manufacturing services by providing a full range of medical devices, from hand-held and medium-sized products, such as ultrasound systems and dermatological lasers, to highly complex equipment that includes computed tomography (CT) equipment and complete nuclear medicine gantries and tables.