Electronics manufacturing services (EMS) provider Sanmina-SCI announced that its Monterrey, Mexico facility has been awarded ISO 13485 certification for medical device manufacturing.

ISO 13485 is an internationally recognized standard developed to ensure that companies make medical devices that consistently meet government regulations. To be certified to the standard, 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, the company reported.

The Monterrey facility is Sanmina-SCI's 21st plant to achieve ISO 13485 certification. The company has more ISO 13485 qualified facilities than any other Electronics Manufacturing Services (EMS) provider. Nine of Sanmina-SCI’s manufacturing facilities are FDA-registered.

"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.

Sanmina-SCI's Medical division provides OEMs with design, engineering, manufacturing, and reverse-logistics services.