Sanmina-SCI, a global electronics manufacturing services (EMS) company, has reported that its Hungary facility has received ISO 13485 certification for medical device manufacturing.
ISO 13485 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. In order to obtain the certification, Sanmina-SCI demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical device manufacturing and related services.
Sanmina-SCI’s medical division leverages more than 20 years of experience with a large global network of FDA-registered, ISO 13485:2003 compliant medical design and manufacturing facilities in the EMS industry.
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 small and medium-sized products, such as blood pressure monitors and prostate therapy systems to large equipment that includes CT scanners and ultrasound systems.
Gelston Howell, senior vice president of medical division at Sanmina-SCI, said: “We are pleased to have received the ISO 13485 certification which demonstrates Sanmina-SCI’s commitment to maintain the highest medical device manufacturing standards in the EMS industry. Earning this certification represents a significant milestone for our European operations, plus reinforces our leadership position within the medical device market segment and our strategy to support customers on a global basis.”
Dietmar Gunther, executive vice president of European Operations at Sanmina-SCI, said:”Sanmina-SCI’s Tatabanya manufacturing facility has more than ten years experience serving medical, industrial and telecommunications customers. Receiving this key certification for medical device manufacturing opens new opportunities for our strategic customers looking for lower-cost and quality solutions in this region.”