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Sunburst Electronics Achieves New Quality Goals for Medical Device Manufacturing and Design
Company Receives ISO 13485 Certification and ISO 9001 Upgrade
ERIE, Pa.--Sunburst Electronics (www.sunburstelectronics.com), a contract manufacturer of electronic controls in Erie, Pa., has successfully completed key quality objectives that further equip the company to service the medical device manufacturing sector, the company announced recently. Sunburst officially achieved ISO 13485 certification in early February and, through that process, also upgraded its ISO 9001 quality system to the 2008 standard. ISO 13485 is a quality management standard for medical device manufacturing developed by the International Organization for Standardization.
"Sunburst is very proud of our new certification and quality upgrades, and we are excited to be extending our market reach to the medical device industry as a result," said Steve Stamper, vice president of operations at Sunburst. "ISO 13485 certification is not commonly found amongst mid-tier electronic contract manufacturers because of the financial, manpower, and time investments involved."
Sunburst Electronics specializes in developing electronic assemblies (printed circuit boards, chassis assembly, cables and harnesses) for medical devices/equipment, aerospace/aeronautics, military applications, process controls and instrumentation, industrial equipment, measurement systems, and transportation. The company houses its operations in a 31,000-square-foot facility in Erie, Pa., and maintains a separately staffed, 4,000-square-foot repair center specializing in end-of-life product management. As a J-STD-001 facility, the company adheres to stringent standards spanning defect and process control, inspection methodology, and process verification inspection. As a result, the company says, it is well-equipped to serve the military and other high-reliability electronics markets, such as aerospace, medical equipment, and telecommunications.
"Stemming from this certification, Sunburst Electronics has integrated a number of additional quality standards that further compliment our overall quality system, such as risk management, regulatory requirements, and process management for medical device design and manufacturing," said Frank Anderson, quality manager at Sunburst Electronics.
Founded in 1975 and ISO 9001:2008 certified, Sunburst is a wholly-owned subsidiary of Bliley Technologies, Inc., a manufacturer of quartz crystals and crystal oscillators used in the telecommunications, military, and space industries.
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