Segue Manufacturing Xiamen, China Facility Extended ISO 13485 Certification for PCBA manufacturing for Medical Devices

Segue Manufacturing Services a leading manufacturing solutions company making some of the world’s most complex and valuable electronic and mechanical products, today announced that its Xiamen, China, facility has been extended ISO 13485 certification for medical manufacturing of PCBA’s . Achieving this certification recognizes Segue Manufacturing’s world-class manufacturing capabilities, and the company’s focus on meeting the highest levels of quality assurance for products developed for the medical industry.

ISO 13485 is an internationally recognized standard developed to ensure companies provide medical products and devices that consistently meet government regulations for processes. In order to obtain the certification, Segue Manufacturing demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical device manufacturing and related services.

“Manufacturing reliable and safe medical devices is critical to everyone—the doctors and hospitals who utilize these products and the patients who benefit from them,” said Chris Brothers, Vice President of Operations at Segue. “Earning the ISO 13485 certification shows our commitment to produce the best quality products for the medical market and represents a significant accomplishment towards our strategy to support medical customers located in the Asia and North America.”

Segue Manufacturing’s Xiamen, facility has more than 20 years experience serving medical, industrial and communications infrastructure customers. Segue manufactures complex cable and harness assemblies, Box Build and integrated mechanical equipment as well as printed circuit board (PCB) assemblies used in medical devices.

“Receiving this certification for medical device manufacturing opens new opportunities for customers looking for high quality cable, harness and other solutions in North America and Asia,” stated Kevin Gonor, Vice President of Sales and Marketing at Segue Manufacturing. Segue provides a complete solution for complex electro-mechanical assemblies, specializing in manufacturing products that are low to medium volume with a high mix of options and new product introduction in the United States, to high-volume, complex assemblies in Asia. Both locations operate in a streamlined and controlled manufacturing environment through the application of lean manufacturing and JIT/Demand flow principles. To ensure quality products and services, both locations have quality systems that are certified to ISO 9001-2008, ISO 13485, ITAR registered, CE, UL and CSA compliant and certified to IPC 620-A-WHMA and IPCJ-STD-001. In addition, our Xiamen location is certified to TS16949:2009.

“Offshore manufacturing can only be successful if you have a relationship with your contract manufacturer that is built on trust, honesty, and, most importantly, communication,” adds Bill Roderick, President at Segue. “At Segue, we offer the best of both worlds; the opportunity to take advantage of low-cost, off-shore manufacturing while strengthening partnerships and communicating with our offices here in the States.”

About Segue Manufacturing Services

Segue Manufacturing Services is a U.S. owned and operated, global contract manufacturer providing a portfolio of engineering services and manufacturing capabilities from sub-assembly level to complete end-to-end manufacturing in a lean manufacturing environment. We provide our customers a competitive edge through a comprehensive suite of cost-effective manufacturing that is unavailable from most regional contract manufacturers. From low-to-moderate volumes, high-mix production and new product introduction in the United States, we transition to high-volume, complex assemblies at our facility in Xiamen, China.

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Scott Manty

VP Sales & Marketing