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	<title>Medical Device Courses | ma3295 | Mentions</title>
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				<title>enzo.1216 replied to the topic  &#034;Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/58783/</link>
				<pubDate>Mon, 28 Sep 2026 00:54:58 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/ma3295/' rel="nofollow ugc">@ma3295</a> 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&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/should-ai-based-medical-devices-require-the-same-regulatory-approach-as-traditional-medical-devices/#post-24200" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>James Olson replied to the topic  &#034;Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/58697/</link>
				<pubDate>Sat, 26 Sep 2026 23:26:28 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/ma3295/' rel="nofollow ugc">@ma3295</a> 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&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/should-ai-based-medical-devices-require-the-same-regulatory-approach-as-traditional-medical-devices/#post-24169" rel="nofollow ugc">Read more&raquo;</a></p>
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