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enzo.1216 replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" – 3 weeks, 1 day ago
@ma3295 I agree with your point. I think requiring every AI update to go through the same regulatory process as a completely new medical device could become redundant, especially when the update only introduces a small change that does not… Read more»
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James Olson replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" – 3 weeks, 2 days ago
@ma3295 I would agree that reapproval is needed in many cases of updating the AI in a medical device, but not all cases. I view the AI as a part of the device that contributes to the success of the… Read more»
