SigmaTron International, Inc. Earns Quality Certification for Medical Devices at Fremont Facility.ELK GROVE VILLAGE Elk Grove Village, village (1990 pop. 33,429), Cook and Du Page counties, NE Ill., a suburb of Chicago; inc. 1956. With a population of c.100 at the time of its establishment on open farmland, the village has grown dramatically and steadily, largely because of its , Ill. -- Independent Testing Agency, Orion, Verifies Conformance to 13485 Medical Device Manufacturing Quality Standards SigmaTron International, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SGMA SGMA Sporting Goods Manufacturers Association SGMA Southern Gospel Music Association SGMA Sierpinski Gasket Monopole Antenna ), 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 accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. 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 (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Canada and European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community 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 Elk Grove Village is a municipality located in northeastern Illinois adjacent to O'Hare International Airport and the City of Chicago. Elk Grove Village encompasses 10.9 square miles in land area with 10.5 square miles located in Cook County and 0. , Las Vegas Las Vegas (läs vā`gəs), city (1990 pop. 258,295), seat of Clark co., S Nev.; inc. 1911. It is the largest city in Nevada and the center of one of the fastest-growing urban areas in the United States. , Nevada, Acuna, Mexico, Fremont, California For the unincorporated community in Yolo County, California, see . Fremont (IPA: /ˈfriːmɒnt/) is a city in California that was incorporated on January 23, 1956, from the merger of five smaller communities: 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. |
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