Medical device

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Medical device

Description

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.


Reference: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm

» In vitro diagnostic medical device
  • Specifically, a medical device pursues one or more of the following purposes:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • investigation, replacement, modification or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • control of conception;
  • disinfection of medical devices;
  • providing information for medical purposes by means of in vitro examination of specimens derived from the human body;
  • decide if a product is a medical device
  • classify the medical device
  • analyse risks within risk management processes
  • fullfill regulatory requirements



MitoPedia concepts: MitoFit Quality Control System