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Sunburst Receives ISO 13485 Certification
June 5, 2007 |Estimated reading time: Less than a minute
WEST BRIDGEWATER, Mass. Sunburst EMS has been certified to ISO 13485 standard for medical electronic device manufacturing . The full-service EMS provider performs design and prototyping, assembly, supply-chain management, and other value-add services, and considers the ISO certification a requisite for pursuing medical-device OEM business.
ISO 13485, published in 2003, dictates quality-management standards and requirements for a comprehensive management system for design and manufacture of medical devices. Sunburst met ISO 13485 conditions as well as 21 CFR 820 corresponding subparts, said Andrew Chase, president. The EMS provider is RoHS- and WEEE-compliant, with a project-specific lead-free roadmap for manufacturing and production-ready processes.