Latest regulatory certification further validates AVX as a premier supplier of tantalum capacitors for medical device manufacturing.
AVX Corporation (Greenville, SC) has received ISO 13485:2003 certification for its high-reliability tantalum capacitor manufacturing facility, located in Biddeford, Maine.
AVX Biddeford’s latest certification ensures customers that the plant operates a quality management system that complies with strict ISO 13485 requirements for medical device manufacturers.
These requirements emphasize meeting both regulatory and customer requirements, management of risk, and maintaining effective processes for the safe design, manufacture, and distribution of medical devices.
ISO 13485 certification also ensures that the plant’s management system is aligned with the U.S. Food and Drug Administration’s Quality System Regulation (QSR) requirements and several other global regulatory requirements.
“All AVX plants are committed to producing the highest quality components, operating in a safe and environmentally responsible manner, and continually improving manufacturing processes, efficiency, and product quality,” says Bob Fairey, General Manager, AVX Tantalum Corporation.
“Our ISO 13485 certification is our latest achievement with respect to these efforts, as well as a valuable tool that will help us continue to manufacture safe, trusted, and high-quality tantalum capacitors for use in critical medical devices.”
For more information visit www.avx.com.