Sunburst EMS Announces ISO 13485 Certification for Medical Electronics Manufacturing
Sunburst EMS Announces ISO 13485 Certification for Medical Electronics Manufacturing
West Bridgewater, Massachusetts, USA - Sunburst EMS, a flexible, full-service provider of electronics manufacturing services, announces that the company has been certified to ISO 13485, a key standard for companies seeking to manufacture medical electronic devices. ISO 13485, published in 2003, is an important quality management standard and 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).
In making the announcement, 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."
Sunburst EMS is a flexible, full-service provider of a full range of contract electronics manufacturing services, including Design, Prototyping, PCB Assembly, Conformal Coating, Box Build, Supply Chain Management, and more. Sunburst EMS is fully RoHS and WEEE compliant. Sunburst EMS has initiated a lead-free roadmap that can be customized to meet those specific business needs for full lead-free manufacturing and production-ready process. For more information, visit www.sunburstems.com, or contact the company at 70 Pleasant Street, West Bridgewater, MA, 02379; Tel. 508-580-1881.
Press Contact:
Michael L. Martel
Tel. 401-480-3433
E-mail: mmc@mmc-marketing.com
