
Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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What's the Risk of a Buffer Overrun in a Medical Device?
FDA wants people to think about what's the actual risk of using software as a medical device. This is based on how it's used, what other components may exist, or what its interface is. If you intend the product to be used in an way where it is the decision making sort of factor, then the risk is going to be much higher than if it is something that a patient uses to track information online.
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