SMTC Corporation confirmed a strong commitment to continue the expansion into the medical device and life sciences market by achieving ISO 13485:2003 certification at their regional manufacturing centers in Toronto, Canada and San Jose, California and their low cost manufacturing operations in Chihuahua, Mexico.
SMTC provides advanced electronic manufacturing services to a growing number of OEMs in the medical and life sciences market sectors. OEMs look to engage a full range of SMTC value-added services including engineering support, material supply chain design and advanced procurement support, prototyping and product qualification, PCBA assembly through final product & system manufacturing, global distribution, product life cycle management and after-sales support.
"SMTC has a long history in the manufacturing of mission critical, high reliability products in specialized computing, enterprise grade telecommunications and transportation control applications. Our continued expansion in supporting medical and life science OEMs will leverage key aspects of our operational and supply chain capabilities and control processes which have allowed SMTC to develop a strong reputation of manufacturing high quality products," said John Caldwell, President and Chief Executive Officer, SMTC Corporation. The certification of our North American facilities to the ISO 13485:2003 standard affirms that our manufacturing operations are fully capable of meeting the high quality and process control requirements which are fundamental in the outsourcing of medical and life science products."
ISO-13485:2003 is an internationally recognized quality management system and standard for the manufacture of medical devices. The standard is governed by the International Organization for Standardization (ISO). All SMTC manufacturing sites are also registered to the ISO-9001 quality management system standard. Plans to achieve ISO 13485:2003 certification at SMTC's low cost manufacturing operation in China are targeted for 2011.