FREMONT, CALIF. – November 3, 2008 -- American Portwell Technology, Inc., a world-leading innovator in the Industrial PC (IPC) market and a member of the Intel® Embedded and Communications Alliance (Intel ECA), is pleased to announce that it is now registered as conforming to International Organization for Standardization (ISO) 13485:2003, Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes. Perry Johnson Registrars (PJR) performed the ISO audit in early October 2008. The company previously attained ISO 9001:2001 certification in 2004.
Meeting Medical Device QMS Requirements
“Achieving ISO 13485:2003 certification means that American Portwell Technology has met the specified requirements for a medical device quality management system (QMS) and demonstrated its capability to provide medical devices and related services that consistently meet and exceed applicable customer and regulatory requirements,” states K.K. Tong, Portwell’s director of operation & QA.
“The medical devices our customers manufacture come in close contact with patients. They can range from minor support to lifesaving capabilities. So they demand high criteria,” Tong explains. “Forward-looking companies such as American Portwell Technology that establish and implement an ISO 13485 quality system are taking a world class approach to the design, development, manufacture, distribution and servicing of the various computers, components and embedded boards that drive our customers’ medical devices.”
Allen Lee, Portwell’s president adds, “We are extremely pleased that our hard work and effort have earned us this ISO 13485:2003 certification. It will not only strengthen our existing relationships with our medical customers, but could also establish us as the supplier of choice for both custom and standard embedded devices.”
ISO 13485:2003 certification requires accountability and compliance with regulations such as the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (CGMP), maintenance of documentation and traceability of products.
About Perry Johnson Registrars
Perry Johnson Registrars, Inc. (PJR) is a full-service registrar that carries multiple international accreditations. PJR has the authority to recognize organizations for their quality management system’s integrity and conduct the relevant ISO audit. PJR is accredited by the ANSI-ASQ National Accreditation Board (ANAB) to register organizations to ISO 13485 certification. Perry L. Johnson—founder and president of PJR—is one of the world’s foremost authorities in quality, having written more than 15 manuals covering topics from Total Quality Management to Statistical Process Control and ISO/QS-9000
About American Portwell Technology
American Portwell Technology, Inc., is a world-leading innovator in the Industrial PC (IPC) market and a member of the Intel Embedded and Communications Alliance. American Portwell Technology designs, manufactures and markets a complete range of IPC systems, embedded computer boards, communication appliance and Panel-PCs for both OEMs and ODMs. The company is located in Fremont, California. For more information about American Portwell’s extensive turnkey, and private-label branding solutions, call 1-877-APT-8899, email firstname.lastname@example.org or visit us at http://www.portwell.com
American Portwell Technology
American Portwell Technology, Inc.
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