Oct 22, 2024 
STI Electronics, Inc. proudly announces that it has achieved ISO 13485:2016 certification, a globally recognized standard for quality management systems specific to the medical device industry. This certification underscores STI’s dedication to meeting the stringent regulatory and quality requirements necessary to manufacture safe and effective medical devices.
The ISO 13485:2016 certification demonstrates STI Electronics’ commitment to consistent excellence in its processes, ensuring that its products meet the high standards demanded by the healthcare industry. With this certification, STI is now better positioned to support its clients in the medical sector by delivering high-quality products that comply with industry regulations and patient safety standards.
“We are thrilled to receive the ISO 13485:2016 certification,” said David Raby, President & CEO of STI Electronics, Inc. “This accomplishment is a testament to the hard work of our team and our commitment to quality and regulatory compliance in the medical device industry. It also reflects our dedication to continuous improvement, customer satisfaction, and delivering products that our clients can trust.”
STI Electronics has a longstanding history of providing advanced electronics manufacturing and services to a diverse range of industries, including aerospace, defense, and now medical device manufacturing. Achieving the ISO 13485:2016 certification positions the company as a trusted partner in the medical device market, assuring customers that their products meet the highest standards of safety and quality.
About ISO 13485:2016
ISO 13485:2016 is an internationally agreed-upon standard that sets out the requirements for a quality management system specific to the medical devices industry. Organizations certified under ISO 13485:2016 must demonstrate their ability to consistently meet regulatory requirements and customer expectations, ensuring the safety and performance of medical devices.
Since 1982, STI Electronics, Inc. (STI) has been the premier full-service organization for training services, training materials, analytical/failure analysis, prototyping, and contract manufacturing in the electronics industry. For more information, visit www.stiusa.com.
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