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	<title>Medical Device Courses | zbw2 | Mentions</title>
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				<title>nm523@njit.edu replied to the topic  &#034;Regulations with quality&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/23593/</link>
				<pubDate>Mon, 04 Oct 2021 02:56:48 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@zbw2</a> Certain regulations are in place to standardize practices among all medical device companies, not necessarily because these regulations will impact the effectivity of the product. For example, there are strict compendia regulations for how to test certain medical devices&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/regulations-with-quality/paged/2/#post-12951" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>rowel2202 replied to the topic  &#034;Regulations with quality&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22744/</link>
				<pubDate>Thu, 24 Jun 2021 23:58:00 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@Zbw2</a> brought up an intriguing argument regarding market competition encouraging quality. A firm will be concerned with quality if they want to ensure that their product is better than all of its rivals. While I believe this to be true,&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/regulations-with-quality/#post-12158" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>mrlee5 replied to the topic  &#034;Risk Management - Identification&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22713/</link>
				<pubDate>Mon, 21 Jun 2021 23:29:38 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@zbw2</a> spoke on a good system to use when considering risks. They mention that during the brainstorming part of the process, priority should be put on risks associated with the most critical parts of the device that can’t be avoided,&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/risk-management-identification/paged/2/#post-12128" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>k-faulk replied to the topic  &#034;Design Controls in the other countries&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22675/</link>
				<pubDate>Mon, 14 Jun 2021 03:43:06 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@zbw2</a> China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA &#8220;revised [their]&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-controls-in-the-other-countries/paged/3/#post-12092" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>mrlee5 replied to the topic  &#034;Design Controls in the other countries&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/22666/</link>
				<pubDate>Sun, 13 Jun 2021 18:13:40 -0400</pubDate>

									<content:encoded><![CDATA[<p>Posted by: <a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@zbw2</a> China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA &#8220;revised [their]&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-controls-in-the-other-countries/paged/3/#post-12083" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>rv347 replied to the topic  &#034;Regulations with quality&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/16562/</link>
				<pubDate>Wed, 15 May 2019 19:40:21 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@Zbw2</a> made an interesting point about market competition as a motivating factor for quality. A company wants to make sure their product is better than all the competitors, so they will be concerned with quality. While I think this is&#8230; &nbsp; <a href="https://medicaldevicecourses.com/community/quality-control-and-quality-assurance/regulations-with-quality/#post-6234" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>rv347 replied to the topic Regulations with quality in the forum Quality Control and Quality Assurance</title>
				<link>https://medicaldevicecourses.com/activity/p/8336/</link>
				<pubDate>Mon, 08 Oct 2018 01:54:24 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/zbw2/' rel="nofollow ugc">@Zbw2</a> made an interesting point about market competition as a motivating factor for quality. A company wants to make sure their product is better than all the competitors, so they will be concerned with quality. While I think this is a valid point, what happens when there is no competition? What comes to mind is the case with epipen, they charged&hellip;<span class="activity-read-more" id="activity-read-more-8336"><a href="https://medicaldevicecourses.com/activity/p/8336/" rel="nofollow ugc">[Read more]</a></span></p>
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