ADLINK SJMC earns FDA registration as a Contract Manufacturer for medical devices

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

ADLINK Technology announced that its San Jose Manufacturing Center (SJMC) has secured registration with the U.S. Food and Drug Administration (FDA) as a Contract Manufacturer for medical devices. The registration allows ADLINK SJMC to support healthcare innovation while ensuring regulatory compliance.

ADLINK SJMC has fully met its FDA registration requirements. Following project approval, compliant manufacturing can typically begin within 2-4 weeks after product listing submission. This process offers medical device OEMs a path to market while helping to 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's 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 (QMS) for medical devices
• Engineering expertise in embedded computing for healthcare applications
• Experience with edge computing and Artificial Intelligence (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.”