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	<title>Medical Device Courses | James Olson | Mentions</title>
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				<title>aysegultinas replied to the topic  &#034;How Many Design Reviews Are Enough?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/59926/</link>
				<pubDate>Fri, 30 Oct 2026 01:33:36 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/bryan-xavier/' rel="nofollow ugc">@bryan-xavier</a> <a href='https://medicaldevicecourses.com/members/james-olson/' rel="nofollow ugc">@james-olson</a> I agree the user need comes first, but I’m not sure “consensus” works as a threshold. A room agreeing the device works is still an opinion. I think the threshold should be something you can check on paper,&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/how-many-design-reviews-are-enough/#post-24526" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>Sid replied to the topic  &#034;Quality Assurance vs. Quality Control&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/58875/</link>
				<pubDate>Sun, 04 Oct 2026 22:46:50 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/james-olson/' rel="nofollow ugc">@james-olson</a> I agree that QA is difficult because it is proactive but I would stress that in medical devices QC may not always be a back-up because some processes include barriers, seals, weldings, and sterilization that lead to outcomes that&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/quality-assurance-vs-quality-control/#post-24271" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>saima3690 replied to the topic  &#034;Role of Regulatory Affairs&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/58771/</link>
				<pubDate>Sun, 27 Sep 2026 22:20:09 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/james-olson/' rel="nofollow ugc">@james-olson</a> I also had a similar impression as yours and thought that it was mostly quality assurance. After this week&#8217;s lecture I feel like it would be difficult to name one particular department, as all are interconnected, and I would&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/role-of-regulatory-affairs/#post-24189" rel="nofollow ugc">Read more&raquo;</a></p>
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