7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Further, as associated risk increases the potential benefit to the patient must also increase.ĭiscovery of what would be considered a medical device by modern standards dates as far back as c. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Artificial pacemaker, a Class III device in the United StatesĪ medical device is any device intended to be used for medical purposes.Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country.
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