November 29, 2010
Tegra Medical Certified to ISO 13485:2003 and ISO 9001:2008 in Costa Rica Facility
FRANKLIN, MA–Tegra Medical has been awarded ISO 13485:2003 and ISO 9001:2008 registration by its notified body, TÜV SÜD America Inc.
Tegra Medical acquired the Costa Rica operation on June 28, 2010 and moved quickly to install the same quality system and ERP platform that is utilized in its two Massachusetts facilities. The new certificate number is S 951 10 5627 and expires on November 28, 2013.
“We’re pleased to achieve this milestone as we develop our Costa Rica operation into a state-of-the-art medical contract manufacturer,” said Bob Roche, President & CEO. “In addition to the investments in quality and information systems, we have completed the build-out of our Class 7-controlled manufacturing environment and taken delivery of our first two Swiss machining centers to complement the machining equipment already in place. We will continue to expand the manufacturing capabilities and capacity of this site to keep pace with our customers’ growing demands.”