Webinar: Benefit-risk evaluation of an AI/ML enabled medical device

One of the most challenging exercises during risk management of a medical device is the evaluation of overall residual risk relative to the benefits of its intended use.
➡️This is because there is no cookie-cutter formula and this evaluation generally involves a lot of (clinical) judgment.
➡️When it comes to benefit-risk assessment of an AI/ML enabled device, this exercise is even more challenging because of so many unknowns associated with this rapidly evolving technology.
✅What if we could see some real-world examples?
➡️This webinar illustrates a step-by-step process to conduct a benefit-risk evaluation of a medical device using a worksheet from a FDA guidance document.
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