Among medical device products, small bone screws, sphygmomanometers, large to operating beds, ultrasound systems, etc., are closely related to human health. Therefore, the manufacturing quality of the medical device industry and the safety, effectiveness and stability of the production process require strict control. In recent years, with the continuous development of the domestic medical device industry, more and more enterprises are able to export their products to developed regions such as Europe and the United States. The strict international industry standards have become new challenges for many medical devices.
Not only can help companies achieve controllability and traceability management of the manufacturing process, it assists the FDA (FDA is the abbreviation of Food and Drug Administration, internationally, FDA is recognized as the world's largest food And one of the drug regulatory agencies. Many other countries seek and receive FDA's help to promote and monitor the safety of their domestic products.) The certification of other regulations is the best choice for the construction of information management in medical equipment enterprises in China.