Sunburst EMS has been certified to ISO 13485, a key standard for companies seeking to manufacture medical electronic devices. ISO 13485, published in 2003, represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as ISO 46001 and ISO 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). Andrew Chase, President, said, “Achieving ISO 13485 certification and (CGMP) implementation of 21 CFR 820 corresponding subparts is an important milestone for Sunburst EMS. It’s not only a sign of our ongoing dedication to quality manufacturing, but also demonstrates our readiness to take on the very demanding challenge of building medical devices that must be robust and reliable.” The company is fully RoHS and WEEE compliant.
EPP Europe 412
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