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  • ala26 replied to the topic "What is Risk-benefit analysis ?"6 years ago

    Risk-benefit factors for assessment of medical device risk includes:
    1) Severity of harm
    2) Likelihood of risk
    3) distribution of nonconforming devices
    4) duration of exposure to population
    5) False-positive or false-negative results
    6) tolerance of risk
    7) risk factors for healthcare professionals and caregivers