Sierra Circuits Achieves ISO 13485 Certification
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Sierra Proto Express
1108 W. Evelyn Ave.
Sunnyvale, CA, 94086
Press release date: June 16, 2011
» Supports special requirements of medical device manufacturers
Sunnyvale, CA - June 16, 2011 - Sierra Circuits, the leader in QuickTurn HDI PCBs, has announced that it has achieved ISO 13485:2003 certification, enabling it to meet the needs of the medical manufacturing community.
ISO 13485 complements the more commonly-known ISO 9001 standard, and provides a comprehensive quality management system for the design and manufacture of medical devices. Some of the specific requirements included in the ISO 13485:2003 standard include inspection and traceability, process documentation and validation, and verification of the effectiveness of preventative or corrective actions.
"Medical device manufacturers often require small form-factors or other capabilities that HDI PCB designs can support," said Amit Bahl, Marketing Director at Sierra Circuits. "Our ISO 13485 certification now enables us to provide those capabilities under the strict quality management procedures required for these devices. In particular, product traceability through rigorous record keeping is a critical requirement in the medical device manufacturing community."
Sierra Circuits can not only meet the stringent ISO 13485:2003 requirements for PCB Fabrication and PCB Assembly, but can also support them through its quick-turn design services - further enhancing the value of the certification for medical device manufacturers.
Products meeting the standard are available from the company effective immediately.
About Sierra Circuits
Sierra Circuits is an ISO 9001:2008, ISO 13485:2003, and Milspec MIL-P-55110 certified Printed Circuit Board manufacturer, specializing in HDI, fine line and flex technologies. Focusing on quick-turn prototypes and medium production, our capabilities include multi-layers, fine lines processing, and blind/buried, filled, and micro vias. We also provide PCB Layout and PCB Assembly services. For more information, visit www.protoexpress.com