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 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 balloon catheter manufacturing. Interface has been solely focused on the balloon
catheter market since 1995 and continually sets industry standards through process and
equipment advancements in balloon catheter manufacturing.
Interface has created more than 2,000 balloon designs, and offers balloon
design and development, extruded balloon tubing, balloon contract manufacturing,
plus a comprehensive line of balloon catheter
production and testing equipment. Interface is ISO 13485:2003
certified and operates multiple class 10,000 (ISO Class 7) and 100,000 (ISO Class 8)
clean rooms in three facilities. Interface’s headquarters is located at 27752 El Lazo
Road, Laguna Niguel, California. www.interfaceusa.com Tel 949.448.7056.
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