Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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IMDRF - Software Risk Management
FDA's approach has been when it comes to software that you categorize software risk, let's say, at least within the US. IMDRF brings a different framework into play that FDA seems to be leveraging. The level of concern for software could be minor, moderate, or major,. For software, standalone, a product, you're going to also sort of have that same kind of consideration about is it minor, is it moderate, and is it, or is it major?
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