Sanmina-SCI's Israel Facility Receives ISO 13485:2003 Certification for Medical Devices

Sanmina-SCI Corp.'s Lod, Israel, facility has received ISO 13485:2003 certification for the manufacture of prototypes, printed circuit board assemblies (PCBAs), electro-mechanical assemblies, subsystems and systems for electrical medical devices.

ISO 13485 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. To obtain the certification, Sanmina-SCI demonstrated the ability to consistently meet strict requirements for Quality Management Systems (QMS) applicable to medical device manufacturing and related services.

"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," said Gelston Howell, Senior Vice President of Sanmina-SCI's Medical Division. "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."

"Receiving the ISO 13485:2003 certification clearly demonstrates Sanmina-SCI's dedication to offer worldwide manufacturing locations to its medical customers," stated Samuel Semel, Sanmina-SCI's General Manager and Managing Director for Israel. "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 leverages more than 20 years of experience with a large global network of FDA-registered, ISO 13485:2003 certified medical design and manufacturing facilities. The Medical Division offers medical device Original Equipment Manufacturers (OEMs) complete end-to-end manufacturing services from engineering and manufacturing to logistics and repair/returns management, specializing in 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.