ADLINK San Jose Manufacturing Center (SJMC) Achieves FDA Registration as a Contract Manufacturer, Enhancing Support for Medical Device Customers

FDA establishment registration as a Contract Manufacturer (CM) allows ADLINK SJMC to produce FDA-regulated medical devices for OEM partners

SAN JOSE, Calif., March 25, 2025 /PRNewswire/ -- ADLINK Technology today announced that its San Jose Manufacturing Center (SJMC), a California facility has secured registration with the U.S. Food and Drug Administration (FDA) as a Contract Manufacturer (CM) for medical devices. Being an FDA-registered establishment, ADLINK SJMC supports healthcare innovation while ensuring regulatory compliance.

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ADLINK SJMC has fully met its FDA registration requirements as a Contract Manufacturer in the medical device ecosystem. Following project approval, the facility can typically begin compliant manufacturing within 2-4 weeks after product listing submission, offering medical device OEMs an accelerated path to market while helping them reduce their Total Cost of Ownership (TCO).

"ADLINK's FDA registration as a Contract Manufacturer reflects our commitment to supporting customers with high-quality, compliant manufacturing services," said Sean Butler, CEO of the Americas at ADLINK Technology." As medical devices increasingly integrate advanced computing technologies, we are uniquely positioned to deliver both the technical expertise and regulatory compliance framework that medical device OEMs require. We are ready to assist our customers through the product listing process once specific devices are selected for production."

ADLINK SJMC Contract Manufacturing program for medical devices includes:

• FDA-registered facility with Contract Manufacturer status
• Streamlined 2-4 week process for new device listings
• Specialized manufacturing services for medical device OEMs
• Comprehensive quality management system for medical devices
• Engineering expertise in embedded computing for healthcare applications
• Experience with edge computing and AI implementations for medical systems
• Scalable manufacturing capabilities for diverse medical device categories

"The medical technology industry faces dual challenges – managing increasing device complexity while meeting stringent regulatory requirements," continued Sean Butler. "As an FDA-registered facility, we help OEMs navigate both, offering advanced manufacturing capabilities within a fully compliant environment. This enables faster time-to-market while upholding the highest standards of quality, right in the heart of Silicon Valley."

About ADLINK

ADLINK Technology Inc. is a global leader in edge AI computing, committed to building and transforming the future of connected platforms through innovative solutions. We provide robust industrial and embedded computing solutions for edge devices, edge platforms, and edge services across vertical markets including manufacturing, communications, healthcare, military, aerospace, transportation, and infotainment. Our products include motherboards, blades, chassis, modules, and systems. Our edge software portfolio includes remote device management, and IoT protocols. With operations across North America, Europe, and Asia, ADLINK strives to advance the technologies of tomorrow, ensuring rapid deployment and exceptional customer service. As a leader in edge computing, ADLINK is dedicated to enabling the connected world, pushing the boundaries of technology to create a smarter, safer, and more efficient future.

For more information, please visit: www.adlinktech.com

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SOURCE ADLINK Technology