Laser machining services provider Pulse Systems (Concord, CA) now has ISO 13485:2016- and ISO 9001:2015-certified Quality Systems, which represent the most recent revisions of these widely recognized manufacturing quality standards issued by the International Organization for Standardization (ISO).
The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. This International Standard specifies requirements for a quality management system, where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Pulse Systems has been certified under ISO 13485 continuously since 2009.
While not specific to medical device manufacturing, the ISO 9001 standard specifies broadly applicable requirements for a quality management system for organizations that need to demonstrate their ability to consistently provide products and services that meet both customer requirements, as well as applicable statutory and regulatory requirements. Pulse Systems first adopted the ISO 9001 standard in 2006.
The company provides precision machining of metal components for the medical device industry, including implantable devices such as endovascular stents. Founded in 1998, it performs precision laser machining of tubular and flat metal components and value-added services such as laser welding, CNC screw machining, Nitinol shape-setting and electropolishing, and Class 10,000 cleanroom assembly. The company specializes in rapid turnaround of prototype parts, and can support full production volumes through its manufacturing operations.
For more information, please visit www.pulsesystems.com.