![]() Most importantly are the European Commission (EC) Medical Device Directives and the United States Food Drug Administration regulations. 1 Therefore, medical devices are governed by strict regulations which are set by the different countries in which manufacturers are intending to launch their products. 2 At the same time, medical error is considered among the top leading causes of death in the United States, ranked third after heart disease and cancer and accounting for over 250,000 deaths annually. 4 Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 22, 000 generic devices groups. ![]() A medical device can include any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related articles, intended by the manufacturer to be used, alone or in combination, for human beings. There is no doubt that the role of medical devices has become pivotal in safeguarding the wellbeing of the progressively health-conscious population. ![]() Review of Medical Devices’ Regulatory Requirements ![]()
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