Medical industry supplier gains broader context for the Quality Systems utilized to manufacture precision device components.
CONCORD, CA, February 6, 2012 – Pulse Systems announced today that the Company’s ISO 13485 and ISO 9001 certifications have been expanded. Both certifications under the International Organization for Standardization (ISO) quality systems standards were recently broadened to the business scope of “contract manufacturing of precision machined components including secondary processing for the medical device industry”.
“Our recent enhancement of these widely-recognized quality certifications highlights our on-going commitment to providing top-tier contract manufacturing services to the medical device industry. This latest improvement to our Quality Systems certifications enables us to offer medical device manufacturers a wide range of conventional machining services, in addition to our well-established laser processing capabilities,” said Herb Bellucci, President and CEO of Pulse Systems, commenting on the significance of the announcement.
“Customers can take full advantage of our ever-increasing skill set, ranging from screw machining of very small metal parts, to laser machining of intricate hypotube components, all the way to laser welding of catheter sub-assemblies in our Class 10,000 cleanroom – and be confident that the processes across our entire gamut of capabilities are covered under our ISO 13485 and ISO 9001 certified quality system” stated Scott Nierotka, Director of Engineering & Quality, who led the certification effort for the company.
The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. This standard defines 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 specifications and regulatory requirements. Pulse Systems has been certified under ISO 13485 since 2009.
While not specific to medical device manufacturing, ISO 9001 is intended to enhance customer satisfaction through the effective application of a quality management system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Pulse Systems has been certified under ISO 9001 continuously since 2006.
About Pulse Systems
Pulse Systems provides precision machining of metal components for the medical device industry, including implantable devices such as endovascular stents. Founded in 1998, the Company provides precision laser machining of tubular metal components and value-added services such as laser welding, CNC screw machining, electropolishing, Nitinol shape-setting, microblasting, and Class 10,000 cleanroom assembly. Pulse Systems specializes in rapid turnaround of prototype parts, and can support full production volumes through its ISO 13485:2003 and ISO 9001:2008 certified manufacturing operations. To learn more about Pulse Systems, please visitour website at www.pulsesystems.com.
Pulse Systems will be exhibiting at the MD&M West tradeshow in Anaheim February 14 - 16, 2012 (Booth 3426). Representatives will be available to discuss how the Company can help solve your medical device manufacturing needs.
Herbert J. Bellucci, President & CEO
4090 Nelson Ave.
Concord, CA 94520
Email: [email protected]
Telephone: (925) 798-4080