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  • jr377 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 10 months ago

    From best to worst option for each risk level-
    High risk: Avoidance, Mitigation, Transference, Acceptance
    Medium risk: Mitigation, Transference, Avoidance, Acceptance
    Low risk: Acceptance, Transference, Mitigation, Avoidance

    High risks need to be dealt with or else you may have major issues in the future including large lawsuits. The last thing you should do is accept it, and mitigating it is less optimal than fixing the issue or lowering the risk.
    Medium risk requires attention, but it doesn’t need to be completely avoided because it could cost more in the long run rather than mitigating or transferring the risk.
    Low risk requires the least attention and shouldn’t require avoidance or maybe even mitigation, due to the possibly high costs for a relatively small issue.

    Most of these rankings are based off of cost, because it’s the most factor to companies. Making a “perfect” product might cost too much for people to buy. There’s no point in making a product if no one wants it.