ERIE, Pa. – Sunburst Electronics, a contract manufacturer of electronic controls in Erie, Pa., is in the final stages of gaining ISO 13485 certification – a quality management standard for medical device manufacturing developed by the International Organization for Standardization. The company plans to extend its medical device industry reach, as a result.

“Gaining this certification affords our medical customers the confidence that Sunburst maintains the same high standards of quality practices and processes that they are accountable for, and also enables them to positively fulfill a critical checkpoint in their quality assessment process for qualifying a contract manufacturing partner,” said Kevin McDonough, Vice President of Sales and Marketing at Sunburst.

ISO 13485 certification is fast becoming an absolute requirement in the medical device manufacturing industry but is not as common amongst mid-tier electronic contract manufacturers since the certification demands significant time, manpower and financial investments.

Through its ISO 13485 certification, Sunburst Electronics will incorporate specific quality standards for risk management, meeting customer and regulatory requirements, and process management for medical device manufacturing. The company’s current ISO 9001:2000 certification has set the foundation for this new initiative and propels Sunburst’s ongoing commitment to both customer satisfaction and continuous quality improvement.

Sunburst’s ISO 13485 certification is pending by early 2009 via QMI - SAI Global, North America’s leading management systems registrar. QMI - SAI Global certificates are recognized and accepted worldwide; and the organization is accredited by a number of organizations including but not limited to the American National Standards Institute, the Registrar Accreditation Board of the USA, and the Standards Council of Canada.