CONCORD, Calif., June 13, 2018 /PRNewswire/ -- Pulse Systems
announced today that the Company's ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions
of both standards. The company's Quality Systems are now certified to the ISO 13485:2016 and ISO 9001:2015 standards, which
represent the most recent revisions of these widely recognized manufacturing quality standards issued by the International
Organization for Standardization (ISO).
"Our recent upgrade of these widely-recognized ISO quality certifications represents the culmination of significant effort by
our entire quality, technical, and operations team," said Herb Bellucci, President and CEO of
Pulse Systems. "This latest company achievement highlights our on-going commitment to providing top-tier contract manufacturing
services to the medical device industry."
Scott Nierotka, Pulse Systems' Director of Engineering & Quality, who led the successful
upgrade project for the company, said, "We're very proud of our many accomplishments at Pulse, from our pioneering work in
developing and expanding our production-level laser machining capabilities for the medical device industry to the extension of
our capabilities into laser welding, small part CNC machining, and Nitinol post-processing, all under our ISO certified Quality
Systems. These latest revisions of the ISO standards incorporate the current thinking in risk management and adjust our focus
from following internal processes toward meeting the complex needs of our external customers and regulatory agencies."
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 which 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.
About Pulse Systems
Pulse Systems, a wholly-owned subsidiary of United American Healthcare Corporation (OTC: UAHC), provides precision
machining of metal components for the medical device industry, including implantable devices such as endovascular stents. Founded
in 1998, the Company 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. Pulse
Systems specializes in rapid turnaround of prototype parts, and can support full production volumes through its ISO 13485:2016
and ISO 9001:2015 certified manufacturing operations. To learn more about Pulse Systems, or to obtain copies of the Company's
newly updated ISO certificates, please visit our website at www.pulsesystems.com.
Pulse Systems is exhibiting at the MD&M East tradeshow, at the Javits Convention Center in New
York, June 12-14, 2018. Pulse Systems representatives will be available at Booth 439 to
discuss the Company's manufacturing capabilities.
Herbert J. Bellucci
President & CEO Pulse Systems
hbellucci@pulsesystems.com
(925) 798-4080
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SOURCE Pulse Systems