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ON Semi awarded ISO 13485 certification
ON Semiconductor's Burlington, Canada advanced packaging facility has received ISO 13485:2003 certification, the international quality management system standard for the design and manufacture of medical devices.
The 95,000-square-foot purpose-built plant, which employs 135 people, specialises in the design and manufacturing of highly miniaturised System-in-Package (SiP) custom assemblies for use in implantable and body-worn medical devices. “Miniaturisation is a key trend in medical devices; by integrating multiple die and discrete components manufactured with diverse technologies in a stacked architecture, significant space savings and improved system performance is achieved,” said Robert Tong, vice president of ON Semiconductor’s Medical Division. “Manufacturers designing applications such as hearing aids, continuous blood glucose monitors and implantable defibrillators are constantly challenged to find new ways to further reduce the size of their devices, driving demand for innovative packaging approaches.” “This certification validates our company’s quality management system, commitment to the medical market and processes for the design and manufacture of highly miniaturised System-in-Packages (SiPs) demanded by the medical industry,” commented Keenan Evans, senior vice president of Quality at ON Semiconductor. “This milestone affirms our commitment to satisfy prevailing quality requirements and compliance to applicable regulations and gives additional confidence to customers who know they have partnered with an organisation that is certified in delivering high-quality advanced packaging solutions through a well-defined quality system.”
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