12/28/2007 - Interface Receives ISO 13485:2003 Certification
Laguna Niguel – December 18, 2007 – Medical device manufacturer Interface Associates of Laguna Niguel, California today announced that it has achieved ISO 13485:2003 certification. “We’re very proud of this achievement that was made possible by the hard work of the entire Interface team,” commented Gary Curtis, President & CEO. “This demonstrates our commitment to our customers to provide the highest level of service and excellence in catheter manufacturing.” The ISO 13485 standard is an internationally recognized Medical Device Quality Management System (QMS) that indicates the manufacturer has implemented and follows a comprehensive quality management system for the manufacturing and sale of medical devices.
Interface Catheter Solutions is the only vertically integrated provider of outsourced solutions for catheter manufacturing. Founded in 1995 as a manufacturer of production equipment for balloon and catheter manufacturers the company has created more than 2,000 balloon designs. Interface offers balloon and catheter design and development, extruded balloon tubing, balloon contract manufacturing, catheter contract manufacturing, plus a comprehensive line of balloon catheter production and testing equipment. Interface is ISO 13485:2003 and ISO 9001:2000 certified and operates multiple class 10,000 (ISO Class 7) and 100,000 (ISO Class 8) clean rooms. Interface’s headquarters are located at 27752 El Lazo Road, Laguna Niguel, California. www.interfaceusa.com Tel 949.448.7056.
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