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  • Foryou Medical Electronics Passed the US FDA Site Audit
  • 21/06/2013

  •          From June 17th to 20th, 2013, US FDA officer conducted a 4-day site audit to Foryou Medical Electronics Co., Ltd about QSR820 R&D and production quality management system. Foryou Medical Electronics passed the audit and became the first medical device manufacturer which passed US FDA site audit in Huizhou. After being the first and only NPWT system manufacturer in China which achieved the approval of US FDA 510k and permission for entering the US market, Foryou Medical Electronics became the first and only NPWT manufacturer in China which passed the US FDA site audit.
             FDA, U.S. Food and Drug Administration, is a federal government institution which is responsible for supervision and administration of food, drug, and medical device. It is called the strictest medical device supervision institution of the world. Its site audit result is thought to be a ruler of the practice level of measuring medical device quality management standard. US FDA is trusted by specialists and the public with its reputation and professional level. Its strict inspection and evaluation provide well security for healthy and safety. It won the good reputation of being the health guardian angel of American and it has great influence in the US and even all over the world.
             So far, it is reported that the amount of Chinese medical device enterprises which have accepted the site audit of US FDA is less than 200, among which Foryou Medical Electronics is ranked top 50. It is the achievement of all Foryou colleagues who strictly enforced the laws and regulations such as QSR820, ISO13485, MDD93/42/EEC and the quality management system of Foryou Medical Electronics.
             The medical devices are related to life & health. To ensure product quality, all colleagues paid great effort to maintain the R&D and production quality system to promote product safety and effectiveness. Hard work results in great harvest. In 2012, the Company became the first NPWT system manufacturer which achieved NPWT system CE certificate and EU R&D production quality management system certificate. In 2013, the Company became the first NPWT manufacturer which achieved approval (FDA 510k) of entering the US market and the first NPWT manufacturer which passed US FDA site audit.
             With 17 years of R&D and production experience in medical devices together with 27 years in electronics products, we are devoted to developing high cost-effective NPWT systems.

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