
12 Sep 2007
UPG SUZHOU PLANT AWARDED ISO 13485 CERTIFICATION
Suzhou, China, August 28, 2007 -- – UPG (Suzhou) EPZ Company, Ltd. has been awarded ISO 13485 2003 certification, which is the international quality management standard for Class 2 medical device manufacturing. UPZ Suzhou joins three other UPG medical manufacturing facilities with ISO 13485 2003 certification. These operations are located in Chicopee, Massachusetts and Fremont, California in the U.S. and in Tijuana, Mexico. As a global contract manufacturer, UPG will use the ISO standard in serving its growing list of medical OEMs seeking U.S. manufacturing standards in the transfer of medical device manufacturing to China.
The 115,800 square-foot UPG facility, located in Export Processing Zone B, features a Class 100,000 clean room, molding/assembly and FDA registration. UPG also operates a second manufacturing facility in the Suzhou Industrial Park as well as UTG, United Tooling Group, a tool design, fabrication and development center.
“ISO 13485 2003 adds value to our Suzhou EPZ services for Class 2 medical devices, which include tool design and fabrication, quality and validation protocols, assembly, form/fill/seal packaging, supply chain management and sterilization processes,” says Tom Opielowski, vice president of UPG/Asia. “Our customers have consistently rated us as a top facility for Class 2 medical device manufacturing in China. “
“We believe our competitive prices, our full range of services, and U.S.-initiated standards of quality and reliability have set us apart in this marketplace,” says Matt Langton, Vice President of UPG. “Since we established a presence here in 2002, we have developed longstanding relationships with major U.S. and European manufacturers of medical products. To serve their needs, we are continuing to assist them in transfer of manufacturing of existing products in addition to the development of new programs for medical assemblies.”
UPG services include application design, tooling engineering, processing, manufacturing, program management and supply chain management for projects that range from injection-molded plastic components to semi-finished subassemblies to multifaceted fully-finished final products. In addition to the medical industry, the company also serves electronics, consumer and automotive markets.
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About UPG
Headquartered in Oak Brook, Ill, UPG (www.upgintl.com) is among the top global contract manufacturers. With more than 615,000 square feet of manufacturing capacity and 300 molding machines in 11 facilities in the United States, Mexico, Europe and China, UPG is dedicated to being the leading international provider of outsourced product development and manufacturing solutions.