4L Health Passed the US FDA Site Re-Audit -- MEDICA - World Forum for Medicine


4L Health Co., Ltd

4L Health Passed the US FDA Site Re-Audit

From Oct. 24th to 27th, 2016, US FDA officer conducted a 4-day site re-audit to 4L Health Co., Ltd. about QSR820 R&D and production quality management system. 4L Health passed the audit and became the first medical device manufacturer which passed the US FDA site re-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, as well as the first and only NPWT manufacturer in China which passed the US FDA site audit, 4L Health became the first and sole NPWT manufacturer in China which passed the US FDA site re-audit. It is the achievement of all 4L Health colleagues who strictly enforced the laws and regulations such as QSR820, ISO13485, MDD93/42/EEC and the quality management system of 4L Health.

US 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 said to be the strictest medical device supervision institution of the world. Its onsite audit result is thought to be a ruler to measure the practice level of medical device quality management standard. FDA is trusted by specialists and the public with its reputation and professionalism. Its strict inspection and evaluation provide security for healthy and safety. It won good reputation of being the health guardian angel of American and it has great influence in the US and even the whole world.

The medical devices are related to life & health. To ensure product quality, all colleagues paid great efforts to maintain the R&D and production quality system to promote product safety and effectiveness.

With 21 years of R&D and production experience in medical devices together with 31 years history in electronics products, we are devoted to developing the highest cost-effective NPWT systems.

4L: For Love, For Life.


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