Airtronics Metal Products Earns ISO 13485 Certification

This key medical certification validates Airtronics' high quality standards and its ability to provide medical components that consistently meet customer and regulatory requirements

SAN JOSE, Calif., January 13, 2010 Airtronics Metal Products, a sheet metal design, engineering and precision manufacturing company, has received ISO 13485:2003 certification from TÜV SÜD, an international quality management systems certification body.

This certification marks a major milestone in Airtronics’ 50-year history, validating the company's high quality standards and its commitment to expanding into the medical device industry. Airtronics also upgraded its ISO 9001:2000 to ISO 9001:2008 certification.

ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Standardization Organization (ISO).  To become ISO 13485 certified, companies must implement and maintain a medical device QMS that has tight change control and full traceability, and that ensures steps have been taken to identify, manage, and minimize the risks involved in the design, manufacture and distribution of medical devices.

“This certification represents the dedication and teamwork of everyone in the company to continually monitor quality and consistently follow well-organized processes,” said Jeff Burke, Airtronics president and CEO. “ISO 13485 verifies our ability to produce high-precision medical components and complex assemblies that consistently meet customer needs and regulatory requirements.

“We are particularly pleased to have been given this accolade at our first attempt,” he added.

About Airtronics
Airtronics Metal Products, Inc. is a full-service, one-stop precision sheet metal products company that serves a variety of industries, including semiconductor, medical, networking, food processing, architectural and consumer electronics. Founded in 1960, Airtronics provides standard and custom engineering, design, production and value-added manufacturing services using the latest in CAD design, production equipment and ERP systems. Operating from its facility in San Jose's Enterprise Zone, Airtronics serves technology leaders in Northern California and throughout the world. The company is ISO 9001:2008 registered and can be reached at 408-977-7800 or on the Web at www.airtronics.com.