10/14/2023 0 Comments Iso 13485 quality manual![]() 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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