SunTech Certify Management to ISO 13485:2003 Standard
26 September 2005
Research Triangle Park, NC, USA, September 26, 2005 - SunTech Medical, Inc., one of the world’s leading manufacturers of Blood Pressure technology, announced today that the Company's management system has been certified to ISO 13485:2003. Intertek, acted as independent third party registrar for the general audit and certification of SunTech Medical’s quality management system.
ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is harmonized with the U.S. FDA's good manufacturing practices. SunTech Medical has actively pursued this certification as part of an ongoing commitment to achieve compliance with regulatory requirements in response to the needs of the medical community at a global level.
"SunTech Medical has always been committed to providing the highest levels of service excellence,” according to Dayn McBee, CEO SunTech Medical. “Achieving ISO 13485 demonstrates that our focus remains on quality, world-class performance and dedication to deliver on the promises we make to our customers, partners and employees.”
"This certification is the direct result of the hard work by the entire SunTech Medical team. Our employees have enthusiastically embraced the values of quality with the purpose of meeting customer and regulatory requirements," added Keith Robinson, Director of Customer Service and Quality, SunTech Medical.
About SunTech Medical, Inc.: SunTech Medical, Inc., located in Research Triangle Park, N.C., is the world leader in motion-tolerant, non-invasive blood pressure monitoring products and technology. SunTech offers products for 24-hour ambulatory BP monitoring, cardiac stress BP monitoring, customizable OEM BP modules and blood pressure cuffs. For more information please visit the company website.
