Denver, CO – November 28, 2012 – Eldon James Corporation – a leading, U.S. based manufacturer of plastic tubing and fittings – announced today that they have received the ISO 13485:2003 certification demonstrating their commitment to the highest standards of the medical device market for their tubing and fittings.
With continued development and innovations in products for the medical equipment market, Eldon James took another step as a key manufacturer of tubing and fittings within this arena. With the announcement of their ISO 13485:2003 certification, Eldon James has further strengthened their position to better serve the medical equipment industry. ISO 13485 is an internationally recognized standardization system that represents the requirements for a comprehensive management system for the design, development, manufacturing and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective devices.
The certification confirms Eldon James’ commitment to product quality that consistently meets customer and regulatory requirements. “The worldwide regulatory environment continues to influence manufacturers marketing medical products,” stated Markus Pratz, International Business Development Manager for Eldon James. “The ISO 13485 certification is very important to our customers in the medical equipment industry, so this is a significant achievement for us.”
Not only has their PVC-Free solutions given Eldon James excellent new opportunities with their tubing and fittings for the medical equipment industry, but they continue to be one of the only manufacturers that produces, assembles and packages tubing and fittings all within a single clean room environment. Now with the ISO 13485 certification, Eldon James is emerging as a top strategic partner for several of the top medical equipment manufacturers in the US and internationally.
For more information, visit www.eldonjames.com/ISO13485.