Medical device adverse event means

Adverse events of medical devices are all kinds of harmful events that have occurred under normal use of marketed medical devices, causing or likely to cause harm to human beings. Medical devices bring people the intended use, but also have certain potential risks.

Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software. Medical devices include medical equipment and medical consumables. Efficacy is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or only in an ancillary manner although these means are involved.

Medical device industry involves medicine, machinery, electronics, plastics and other industries, is a multidisciplinary cross, knowledge-intensive, capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment is digital and computerized, is a multidisciplinary, cross-field crystallization of modern high technology, its product technology content is high, high profits, and therefore the various scientific and technological powers, international large-scale companies compete with each other on the heights of the higher barriers to entry. Even in the industry as a whole, lower gross margins, input is not high in the sub-industry will continue to have a higher technological content of the products, and from this spawned a number of enterprises with strong profitability. Therefore, the overall trend of the industry is high input, high yield.