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SMTC Corp.'s manufacturing facility in Dongguan, China has been awarded ISO 13485 certification for medical device manufacturing. This certification recognizes SMTC's world-class manufacturing capabilities and its focus on meeting the highest levels of quality assurance for products developed for the medical industry. ISO 13485 is an internationally recognized standard developed to ensure companies provide medical devices that consistently meet government regulations.
"Earning the ISO 13485 certification shows our commitment to producing the highest quality devices for both the medical & life science markets," said Sushil Dhiman, president and chief executive officer, SMTC. "Our medical OEMs leverage the full range of SMTC's custom solution services, including design for manufacturability and testability, procurement, quick-turn prototyping, assembly, final system build, comprehensive supply chain management, global distribution, and after market support."
SMTC provides advanced electronic manufacturing services to OEMs in the medical and life sciences sectors. These services support the safe deployment and execution of medical products, including the ability to deliver product recall, traceability, record retention, and risk management.
"This is an important milestone for SMTC as we extend our medical device manufacturing and engineering services in all SMTC factories worldwide," said Josh Chien, senior vice president of worldwide sales & marketing. "This certification is a further demonstration of SMTC's ongoing commitment to our focus on providing solutions to manufacture finished devices for medical OEMs."