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	<title>Medical Device Courses | alexandrabuga | Mentions</title>
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				<title>arianaburch replied to the topic  &#034;Informed consent: What if Henrietta Lacks checked No for research use?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23445/</link>
				<pubDate>Fri, 24 Sep 2021 22:25:27 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/informed-consent-what-if-henrietta-lacks-checked-no-for-research-use-2/paged/4/#post-12800" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>Justinjett replied to the topic  &#034;Informed consent: What if Henrietta Lacks checked No for research use?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23427/</link>
				<pubDate>Thu, 23 Sep 2021 03:15:52 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/informed-consent-what-if-henrietta-lacks-checked-no-for-research-use-2/paged/3/#post-12791" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>kc4310 replied to the topic  &#034;Informed consent: What if Henrietta Lacks checked No for research use?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22614/</link>
				<pubDate>Mon, 07 Jun 2021 02:59:59 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> Great topic, a nice contrast to typical posts.  I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate.  You made some interesting points; I am ignorant to&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/informed-consent-what-if-henrietta-lacks-checked-no-for-research-use-2/paged/3/#post-12044" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>llefevre replied to the topic  &#034;Informed consent: What if Henrietta Lacks checked No for research use?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22599/</link>
				<pubDate>Sat, 05 Jun 2021 20:00:11 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/informed-consent-what-if-henrietta-lacks-checked-no-for-research-use-2/paged/3/#post-12029" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>ajm73 replied to the topic  &#034;Overlapping activities&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/17939/</link>
				<pubDate>Wed, 15 May 2019 21:44:01 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> I don&#8217;t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is&#8230; &nbsp; <a href="https://medicaldevicecourses.com/community/project-management-process-and-medical-device-development/overlapping-activities/paged/2/#post-7611" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>thuytienlecao replied to the topic  &#034;FDA Considering Updating Quality System Requirements&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/15682/</link>
				<pubDate>Wed, 15 May 2019 19:12:50 -0400</pubDate>

									<content:encoded><![CDATA[<p>Thanks for the article and info <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a>. I agree that it is logical. And it would make things simpler. Other than the points from <a href='https://medicaldevicecourses.com/members/kak33/' rel="nofollow ugc">@kak33</a> comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law&#8230; &nbsp; <a href="https://medicaldevicecourses.com/community/quality-systems-management/fda-considering-updating-quality-system-requirements/#post-5354" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>thuytienlecao replied to the topic  &#034;Simulation 1: Faulty Quality System&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/15078/</link>
				<pubDate>Wed, 15 May 2019 19:02:50 -0400</pubDate>

									<content:encoded><![CDATA[<p>I disagree with <a href='https://medicaldevicecourses.com/members/srg36/' rel="nofollow ugc">@srg36</a> and agree with <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> about the need to update revision number. I think it&#8217;s needed to have all the docs updated once a revision is made. I also agree that it&#8217;s a lot of work and&#8230; &nbsp; <a href="https://medicaldevicecourses.com/community/device-documentation/simulation-1-faulty-quality-system/#post-4750" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>thuytienlecao replied to the topic  &#034;Marketing Strategy- The fifth &#039;P&#039;&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/14597/</link>
				<pubDate>Wed, 15 May 2019 18:58:21 -0400</pubDate>

									<content:encoded><![CDATA[<p>I agree with <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> and <a href='https://medicaldevicecourses.com/members/bb254/' rel="nofollow ugc">@bb254</a> about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to&#8230; &nbsp; <a href="https://medicaldevicecourses.com/community/introduction-to-advanced-medical-device-development/marketing-strategy-the-fifth-p/#post-4269" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>ajm73 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development</title>
				<link>https://medicaldevicecourses.com/activity/p/9839/</link>
				<pubDate>Mon, 11 Mar 2019 02:58:24 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> I don&#8217;t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is the case if there is only one or two people who are the subject matter experts on something and their&hellip;<span class="activity-read-more" id="activity-read-more-9839"><a href="https://medicaldevicecourses.com/activity/p/9839/" rel="nofollow ugc">[Read more]</a></span></p>
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									<slash:comments>0</slash:comments>
				
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				<title>thuytienlecao replied to the topic FDA Considering Updating  Quality System Requirements in the forum Quality Systems Management</title>
				<link>https://medicaldevicecourses.com/activity/p/7184/</link>
				<pubDate>Mon, 09 Apr 2018 00:39:21 -0400</pubDate>

									<content:encoded><![CDATA[<p>Thanks for the article and info <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a>. I agree that it is logical. And it would make things simpler. Other than the points from <a href='https://medicaldevicecourses.com/members/kak33/' rel="nofollow ugc">@kak33</a> comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don&#8217;t think QSR would be replaced&hellip;<span class="activity-read-more" id="activity-read-more-7184"><a href="https://medicaldevicecourses.com/activity/p/7184/" rel="nofollow ugc">[Read more]</a></span></p>
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									<slash:comments>0</slash:comments>
				
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				<title>thuytienlecao replied to the topic Simulation 1: Faulty Quality System in the forum Device Documentation</title>
				<link>https://medicaldevicecourses.com/activity/p/6374/</link>
				<pubDate>Sun, 18 Feb 2018 22:18:19 -0500</pubDate>

									<content:encoded><![CDATA[<p>I disagree with <a href='https://medicaldevicecourses.com/members/srg36/' rel="nofollow ugc">@srg36</a> and agree with <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> about the need to update revision number. I think it&#8217;s needed to have all the docs updated once a revision is made. I also agree that it&#8217;s a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document&hellip;<span class="activity-read-more" id="activity-read-more-6374"><a href="https://medicaldevicecourses.com/activity/p/6374/" rel="nofollow ugc">[Read more]</a></span></p>
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									<slash:comments>0</slash:comments>
				
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				<title>thuytienlecao replied to the topic Marketing  Strategy- The fifth &#039;P&#039; in the forum Introduction to Advanced Medical Device Development</title>
				<link>https://medicaldevicecourses.com/activity/p/5737/</link>
				<pubDate>Mon, 22 Jan 2018 02:15:37 -0500</pubDate>

									<content:encoded><![CDATA[<p>I agree with <a href='https://medicaldevicecourses.com/members/alexandrabuga/' rel="nofollow ugc">@alexandrabuga</a> and <a href='https://medicaldevicecourses.com/members/bb254/' rel="nofollow ugc">@bb254</a> about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to social media and social networks, brands and companies can get feedback on where they&hellip;<span class="activity-read-more" id="activity-read-more-5737"><a href="https://medicaldevicecourses.com/activity/p/5737/" rel="nofollow ugc">[Read more]</a></span></p>
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