1. Hl-tech corporation certification is medical equipment manufacturers all over the world (such as: the United States, Japan, Canada, the European Union) is the most acceptable standards. Hl-tech corporation certification including specifically for the requirements of the industry, such as the, active medical equipment, medical equipment and active transplant of sterile medical devices and equipment, and other term in the definition.
2. Hl-tech corporation authentication support those who manufacture or use of medical products and services of enterprises, hl-tech corporation certification to help the enterprise to reduce the risk of unpredictable. Hl-tech corporation certification to improve corporate reputation in the eyes of the customers and authoritative organization.
3. Iso13485:2003 2003 is an independent standard, for only in the field of medical products industry business, hl-tech corporation certification standards can be independent of the ISO9001:2008.
4. Iso13485:2003 2003 has officially promulgated, hl-tech corporation certification standards will cancel and replace iso13485:2003 and ISO13488:1996 1996 (equivalent to China's medical equipment industry standard YY/T0287:1996 and YY/T0288:1996).
5. China's equivalent to the standards for medical devices industry YY/T0287:2003 "medical device quality management system for regulatory requirements" (instead of YY/T0287:1996), and also in September 17, 2003, issued by the state food and drug administration official hl-tech corporation certification standards since April 1, 2004.
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