September 26, 2005 - Research Triangle Park, NC, USA
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.
SunTech Medical's OEM blood pressure technology is used by many of the world's leading patient monitoring and defibrillator equipment manufacturers. Offerings include algorithms for particular patient environments and conditions including patient transport (ambulance, helicopter, or gurney), patient motion (tremors and spasms) and specific patient populations (dialysis, neo-natal, pediatric, bariatric, or veterinarian). SunTech's finished goods solutions include automated blood pressure monitors for stress and exercise testing, our 24-hour ambulatory blood pressure monitor and general and specialized blood pressure cuffs.