Certification to ISO 13485:2003 Standard for Medical Device Manufacturers Demonstrates SunTech Medical's Commitment to Consistently Meet Customer and Regulatory Requirements.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- 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 (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 har·mo·nize v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es v.tr. 1. To bring or come into agreement or harmony. See Synonyms at agree. 2. Music To provide harmony for (a melody). 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 according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Dayn McBee, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and BP modules and blood pressure cuffs. For more information please visit www.SunTechMed.com. |
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