Eldon James Corp., a U.S. based manufacturer of plastic tubing and fittings, has received the ISO 13485:2003 certification demonstrating their commitment to the highest standards of the medical device market for their tubing and fittings.
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,” states 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.”
Eldon James is a woman-owned, Colorado based manufacturer with international reach that has continued to see growth through difficult economies. Their PVC-Free solutions have given them excellent new opportunities with their tubing and fittings for the medical equipment industry. 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 United States and internationally.
For more information, visit the company's website, or call Mark Timbrook at 970-667-2728.