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	<title>eisnersafety &#8211; Eisner Safety Consultants</title>
	<atom:link href="https://eisnersafety.com/author/eisnersafety/feed/" rel="self" type="application/rss+xml" />
	<link>https://eisnersafety.com</link>
	<description>Regulatory &#38; Safety Experts for Global Medical Device Approvals</description>
	<lastBuildDate>Fri, 10 Sep 2010 17:53:41 +0000</lastBuildDate>
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	<title>eisnersafety &#8211; Eisner Safety Consultants</title>
	<link>https://eisnersafety.com</link>
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	<item>
		<title>Have you signed up for our newsletter?</title>
		<link>https://eisnersafety.com/2010/09/10/have-you-signed-up-for-our-newsletter/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=have-you-signed-up-for-our-newsletter</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Fri, 10 Sep 2010 17:53:41 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Medical Device Industry]]></category>
		<category><![CDATA[Medical Device Regulatory]]></category>
		<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory]]></category>
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					<description><![CDATA[Have you signed up for our newsletters? Full of vital Medical Dvc Regulatory, Compliance, &#38; Quality Systems info http://ht.ly/2Cs0V]]></description>
										<content:encoded><![CDATA[<p>Have you signed up for our newsletters? Full of vital Medical Dvc Regulatory, Compliance, &amp; Quality Systems info <a rel="nofollow" href="http://ht.ly/2Cs0V">http://ht.ly/2Cs0V</a></p>
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		<title>Eisner Safety Consultants Website Up &#038; Running Safely</title>
		<link>https://eisnersafety.com/2010/09/03/eisner-safety-consultants-website-up-running-safely/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=eisner-safety-consultants-website-up-running-safely</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Fri, 03 Sep 2010 17:51:42 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/eisner-safety-consultants-webs/</guid>

					<description><![CDATA[Eisner Safety Consultants Website http://ht.ly/2zeE0 back up &#38; safe to use again &#8230; Got hit by a malware attack.]]></description>
										<content:encoded><![CDATA[<p>Eisner Safety Consultants Website <a href="http://ht.ly/2zeE0" rel="nofollow">http://ht.ly/2zeE0</a> back up &amp; safe to use again  &#8230; Got hit by a malware attack.</p>
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		<item>
		<title>CDRH Webinar re: 2 rprts: #510(k) proc &#038; use of Sci in decision making process</title>
		<link>https://eisnersafety.com/2010/08/27/cdrh-webinar-re-2-rprts-510k-process-use-of-science-in-decision-making-proces/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=cdrh-webinar-re-2-rprts-510k-process-use-of-science-in-decision-making-proces</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Fri, 27 Aug 2010 16:09:19 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[510(k)]]></category>
		<category><![CDATA[CDRH]]></category>
		<category><![CDATA[FDA]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/cdrh-webinar-2-rprts-510k/</guid>

					<description><![CDATA[CDRH Webinar to discuss 2 reports: 510(k) premarket review process and the use of science in CDRH’s regulatory decision making process to respond to questions &#38; concerns will be on 31-Aug-10 http://ht.ly/2vNw7]]></description>
										<content:encoded><![CDATA[<p>CDRH Webinar to discuss 2 reports: 510(k) premarket review process and the use of science in CDRH’s regulatory decision making process to respond to questions &amp; concerns will be on 31-Aug-10 <a rel="nofollow" href="http://ht.ly/2vNw7">http://ht.ly/2vNw7</a></p>
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		<title>EU RAPEX &#8211; System for dangerous consumer goods&#8230;</title>
		<link>https://eisnersafety.com/2010/08/23/eu-rapex-system-for-dangerous-consumer-goodnon-food/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=eu-rapex-system-for-dangerous-consumer-goodnon-food</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Mon, 23 Aug 2010 17:32:42 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Consumer Goods]]></category>
		<category><![CDATA[Consumer Products]]></category>
		<category><![CDATA[Dangerous Consumer Products]]></category>
		<category><![CDATA[EU]]></category>
		<category><![CDATA[European Commission]]></category>
		<category><![CDATA[Member States]]></category>
		<category><![CDATA[RAPEX]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/eu-rapid-alert-system-non-food/</guid>

					<description><![CDATA[Europa EU Rapid Alert System non-food consumer products (RAPEX): Doesn&#8217;t include medical devices, pharmaceuticals, and food http://ht.ly/2twrt Source Europa Webpage http://ht.ly/2twrt for the following information on RAPEX: RAPEX is the EU rapid alert system for dangerous consumer products – with the]]></description>
										<content:encoded><![CDATA[<p><span style="font-family: helvetica;">Europa EU Rapid Alert System non-food consumer products (RAPEX): Doesn&#8217;t include medical devices, pharmaceuticals, and food </span><a rel="nofollow" href="http://ht.ly/2twrt"><span style="font-family: helvetica;">http://ht.ly/2twrt</span></a></p>
<p><span style="font-family: helvetica;">Source Europa Webpage </span><a rel="nofollow" href="http://ht.ly/2twrt"><span style="font-family: helvetica;">http://ht.ly/2twrt</span></a><span style="font-family: helvetica;"> for the following information on RAPEX:</span></p>
<p style="padding-left: 30px; "><span style="font-family: helvetica;">RAPEX is the EU rapid alert system for dangerous consumer products – with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. It facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are reported by RAPEX.</span></p>
<p style="padding-left: 30px; "><strong><span style="font-family: helvetica;">How does RAPEX work?</span></strong><span style="font-family: helvetica;"><br />
</span></p>
<ul>
<li>
<ul>
<li><span style="font-family: helvetica;"><strong></strong>When a product (e.g. a toy, a childcare article or a household appliance) is found to be dangerous, the competent national authority takes appropriate action to eliminate the risk. It can withdraw the product from the market, recall it from consumers or issue warnings. The National Contact Point then informs the European Commission (Directorate-General for Health and Consumer Protection) about the product, the risks it poses to consumers and the measures taken by the authority to prevent risks and accidents.</span></li>
<li><span style="font-family: helvetica;">The European Commission disseminates the information that it receives to the National Contact Points of all other EU countries. It publishes weekly overviews of dangerous products and the measures taken to eliminate the risks on the internet.</span></li>
<li><span style="font-family: helvetica;">The National Contact Points in each EU country ensure that the authorities responsible check whether the newly notified dangerous product is present on the market. If so, the authorities take measures to eliminate the risk, either by requiring that the product be withdrawn from the market, by recalling it from consumers or by issuing warnings.</span></li>
</ul>
</li>
</ul>
<p style="padding-left: 30px;"><span style="font-family: helvetica;">There is also a &#8220;RAPEX-CHINA&#8221; system</span></p>
<p style="padding-left: 30px;"><span style="font-family: helvetica;">Lots of great information on this system on the Europa webpage <span style="font-family: helvetica;"> </span><a rel="nofollow" href="http://ht.ly/2twrt"><span style="font-family: helvetica;">http://ht.ly/2twrt</span></a></span></p>
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		<item>
		<title>Just Say No to FDA’s Idea of Transparency? MD&#038;DI</title>
		<link>https://eisnersafety.com/2010/08/20/just-say-no-to-fdas-idea-of-transparency-mddi/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=just-say-no-to-fdas-idea-of-transparency-mddi</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Fri, 20 Aug 2010 00:09:36 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[510(k)]]></category>
		<category><![CDATA[Assessment of 510(k) process]]></category>
		<category><![CDATA[CDRH]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[MD&DI]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/just-say-no-to-fda%e2%80%99s-idea-o/</guid>

					<description><![CDATA[Just Say No to FDA&#8217;s Idea of Transparency from MD&#38;DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process]]></description>
										<content:encoded><![CDATA[<p>Just Say No to FDA&#8217;s Idea of Transparency from MD&amp;DI Magazine Aug-10 <a style="text-decoration: none; color: #0084b4; padding: 0px; margin: 0px;" rel="nofollow noopener noreferrer" href="http://ht.ly/2sa6c" target="_blank">http://ht.ly/2sa6c</a> See our post <a href="http://www.eisnersafety.com/fda-issues-assessments-of-510k-process-use-of-science-in-decision-making/" target="_blank" rel="noopener noreferrer">FDA Issue Assessment of 510(k)</a> for the FDA assessment report on the 510(k) process</p>
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		<item>
		<title>Device Industry Critic to Join CDRH as 1st Deputy Dir of Science?</title>
		<link>https://eisnersafety.com/2010/08/19/device-industry-critic-to-join-to-join-cdrh-as-1st-deputy-dir-of-scienc/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=device-industry-critic-to-join-to-join-cdrh-as-1st-deputy-dir-of-scienc</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Thu, 19 Aug 2010 20:13:00 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[CDRH]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/device-industry-critic-to-join/</guid>

					<description><![CDATA[Device Industry Critic to Join CDRH as first Deputy Director of Science? &#8211; From Medical Device Summit http://ht.ly/2s5c0]]></description>
										<content:encoded><![CDATA[<p>Device Industry Critic to Join CDRH as first Deputy Director of Science? &#8211; From Medical Device Summit <a rel="nofollow" href="http://ht.ly/2s5c0">http://ht.ly/2s5c0</a></p>
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		<title>New Zealand: Draft Recall Proc Medicines &#038; Medical Dvcs</title>
		<link>https://eisnersafety.com/2010/08/19/new-zealand-draft-recall-proc-medicines-and-medical-dvcs/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=new-zealand-draft-recall-proc-medicines-and-medical-dvcs</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Thu, 19 Aug 2010 16:55:56 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Draft Recall Procedure]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[New Zealand]]></category>
		<category><![CDATA[Recall Procedure]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/new-zealand-draft-recall-proc/</guid>

					<description><![CDATA[New Zealand: Draft Recall Procedure &#8211; Medicines &#38; Medical Dvcs &#8211; Comments Due by Aug 27, 2010 http://ht.ly/2rYmM]]></description>
										<content:encoded><![CDATA[<p>New Zealand: Draft Recall Procedure &#8211; Medicines &amp; Medical Dvcs &#8211; Comments Due by Aug 27, 2010 <a rel="nofollow" href="http://ht.ly/2rYmM">http://ht.ly/2rYmM</a></p>
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		<item>
		<title>IMB (Ireland) Advisory Notice Effective Traceability Med Dvcs</title>
		<link>https://eisnersafety.com/2010/08/19/imb-ireland-irish-medicines-board-advisory-notice-effective-traceability-med-dvcs/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=imb-ireland-irish-medicines-board-advisory-notice-effective-traceability-med-dvcs</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Thu, 19 Aug 2010 00:48:51 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Advisory Notice]]></category>
		<category><![CDATA[IMB]]></category>
		<category><![CDATA[Irish Medicines Board]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[Traceability]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/irish-medicines-board-advisory/</guid>

					<description><![CDATA[Irish Medicines Board Advisory Notice Effective Traceability of #Medical Devices issued Aug 13, 2010 pdf version http://ht.ly/2rCjc or html version http://ht.ly/2rCjz]]></description>
										<content:encoded><![CDATA[<p>Irish Medicines Board Advisory Notice Effective Traceability of #<a class="aktt_hashtag" href="http://search.twitter.com/search?q=%23Medical">Medical</a> Devices issued Aug 13, 2010 pdf version <a rel="nofollow" href="http://ht.ly/2rCjc">http://ht.ly/2rCjc</a> or html version <a rel="nofollow" href="http://ht.ly/2rCjz">http://ht.ly/2rCjz</a></p>
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		<title>FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Med Elect Equip Std</title>
		<link>https://eisnersafety.com/2010/08/11/fda-recognizes-ansiaami-es60/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=fda-recognizes-ansiaami-es60</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Wed, 11 Aug 2010 19:24:59 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[60601 series]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1 3rd ed.]]></category>
		<category><![CDATA[AAMI]]></category>
		<category><![CDATA[AAMI ES60601-1]]></category>
		<category><![CDATA[CDRH]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[IEC]]></category>
		<category><![CDATA[IEC60601-1]]></category>
		<category><![CDATA[IEC60601-1 3rd ed.]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/fda-recognizes-ansiaami-es60/</guid>

					<description><![CDATA[#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH]]></description>
										<content:encoded><![CDATA[<p>#<a class="aktt_hashtag" href="http://search.twitter.com/search?q=%23FDA">FDA</a> Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard <a rel="nofollow" href="http://ht.ly/2oiBH">http://ht.ly/2oiBH</a></p>
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		<item>
		<title>Federal Register: Comprehensive List of FDA Guidance Doc&#8217;s</title>
		<link>https://eisnersafety.com/2010/08/10/federal-register-comprehensive-list-of-fda-guidance-docs/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=federal-register-comprehensive-list-of-fda-guidance-docs</link>
		
		<dc:creator><![CDATA[eisnersafety]]></dc:creator>
		<pubDate>Tue, 10 Aug 2010 20:17:39 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Guidance]]></category>
		<category><![CDATA[Federal Register]]></category>
		<category><![CDATA[Guidance Documents]]></category>
		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/federal-register-comprehens/</guid>

					<description><![CDATA[Federal Register  Comprehensive List of FDA Guidance Documents; Notice http://ht.ly/2nKfg]]></description>
										<content:encoded><![CDATA[<p>Federal Register  Comprehensive List of FDA Guidance Documents; Notice <a rel="nofollow" href="http://ht.ly/2nKfg">http://ht.ly/2nKfg</a></p>
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