Rocket EMS Inc., a Silicon Valley EMS provider of printed circuit board (PCB) layout, assembly, test and integration services, has achieved ISO 13485:2003 certification. This internationally recognized standard acknowledges the suitability of the company’s quality management system for the design and manufacture of medical devices.
“The certification of our Quality System, first to ISO 9001:2008 and AS 9100C in March 2012, and now ISO 13485:2003, demonstrates Rocket’s commitment to delivering exceptional product quality to our customers across all fields, including medical, aerospace, telecom, industrial and consumer,” said Michael Kottke, Rocket EMS President.
The primary objective of ISO 13485 is to ensure process quality for layout, development, production, installation and servicing of medical devices. It includes all the requirements of ISO 9001 with emphasis on regulatory requirements as they relate to medical devices.
Rocket EMS, based in San Jose California, is an electronic manufacturing services (EMS) provider specializing in a full suite of new product introduction (NPI) services as well as low and medium volume high-mix production. Combined with Rocket’s strategic partnership with EMS provider EPIC technologies, Rocket can provide services from PCB layout and ultra-quick-turn manufacturing through high-volume production across all product spectrums.