SigmaTron International, Inc. Earns Quality Certification for Medical Devices at Fremont Facility

Business Wire, Dec 22, 2004

ELK GROVE VILLAGE, Ill. -- Independent Testing Agency, Orion, Verifies Conformance to 13485 Medical Device Manufacturing Quality Standards

SigmaTron International, Inc. (NASDAQ:SGMA), an electronic manufacturing services company that provides components, printed circuit board assemblies and turnkey (completely assembled) electronic products, today announced that its Fremont facility has been certified for 13485 medical device manufacturing by Orion Registrar, Inc., a quality and environmental systems registrar, headquartered in the Denver, Colorado area. Orion is internationally accredited and recognized throughout the world for Quality and Environmental Programs.

The 13485 quality standards are specific to medical device quality systems and supplement the more generic ISO 9001 and 9002 standards that apply to many industries. Additional 13485 requirements include those that are critical in the medical device industry: specifically, special processes, design controls, process controls including environmental, traceability, record retention and regulatory actions.

"We are extremely proud of the hard work of our team at the Fremont plant in reaching full compliance to international regulatory standards for medical device manufacturing," Gary R. Fairhead, president and chief executive officer, said. "Manufacturers of Class II, III, and IV medical devices must obtain proper certification to assemble these products in the United States, Canada and European Union member countries. This latest certification is consistent with our commitment to delivering the highest quality design, engineering and manufacturing services worldwide as all of our other manufacturing locations in the United States, Mexico and China are certified to ISO 9001-2000. With these latest certifications, SigmaTron is well positioned to comply with industry manufacturing compliance standards for the medical industry."

Headquartered in Elk Grove Village, IL, SigmaTron International, Inc. is an electronic manufacturing services company that provides components, printed circuit board assemblies and turnkey (completely assembled) electronic products. SigmaTron International, Inc. operates manufacturing facilities in Elk Grove Village, Illinois, Las Vegas, Nevada, Acuna, Mexico, Fremont, California and Suzhou-Wujiang, China. SigmaTron International, Inc. maintains engineering and materials sourcing offices in Taipei, Taiwan.

Note: To the extent any statements in this press release statement may be deemed to be forward looking, such statements should be evaluated in the context of the risks and uncertainties inherent in the Company's business, including the Company's continued dependence on certain significant customers; the continued market acceptance of products and services offered by the Company and its customers; the activities of competitors, some of which may have greater financial or other resources than the Company; the variability of the Company's operating results; the availability and cost of necessary components; the Company's ability to manufacture lead free assemblies by mid - 2006; regulatory compliance; the continued availability and sufficiency of the Company's credit arrangements; changes in U.S., Mexican or Chinese regulations affecting the Company's business; the continued stability of the Mexican and Chinese economic, labor and political conditions, currency fluctuations, and the ability of the Company to manage its growth, including expansion into China and securing financing for the operation in China. These and other factors which may affect the Company's future business and results of operations are identified throughout the Annual Report on Form 10-K, and may be detailed from time to time in the Company's filings with the Securities and Exchange Commission. These statements speak as of the date of this Report and the Company undertakes no obligation to update such statements in light of future events or otherwise.