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	<title>conformity assessment &#8211; Eisner Safety Consultants</title>
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	<link>https://eisnersafety.com</link>
	<description>Regulatory &#38; Safety Experts for Global Medical Device Approvals</description>
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	<title>conformity assessment &#8211; Eisner Safety Consultants</title>
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		<title>GHTF Just Released New &#038; Updated Documents</title>
		<link>https://eisnersafety.com/2012/11/07/ghtf-just-released-new-updated-documents/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=ghtf-just-released-new-updated-documents</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Wed, 07 Nov 2012 08:36:05 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Classification]]></category>
		<category><![CDATA[classification decisions]]></category>
		<category><![CDATA[clinical evidence]]></category>
		<category><![CDATA[Clinical Evidnece]]></category>
		<category><![CDATA[clinical performance]]></category>
		<category><![CDATA[conformity assessment]]></category>
		<category><![CDATA[Essential Principles]]></category>
		<category><![CDATA[GHTF]]></category>
		<category><![CDATA[global harmonization]]></category>
		<category><![CDATA[Global Harmonization Task Force]]></category>
		<category><![CDATA[information exchange]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Classification]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[Nonconformance Grading]]></category>
		<category><![CDATA[Nonconformity Grading System]]></category>
		<category><![CDATA[QMS]]></category>
		<category><![CDATA[quality management system]]></category>
		<category><![CDATA[Quality Management Systems]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[regulatory purposes]]></category>
		<category><![CDATA[Safety & Performance]]></category>
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					<description><![CDATA[The Global Harmonization Task Force (GHTF) recently had a meeting and with that came a slew of final documents that were issued on 2 Nov 2012. &#160; Essential Principles of Safety &#38; Performance of Medical Devices GHTF/SG1/N68:2012 supersedes GHTF/SG1/N41:2005 Principles]]></description>
										<content:encoded><![CDATA[<p><strong><a href="http://www.ghtf.org/" target="_blank" rel="noopener noreferrer">The Global Harmonization Task Force (GHTF)</a></strong> recently had a meeting and with that came a slew of final documents that were issued on 2 Nov 2012.</p>
<p><span id="more-2830"></span></p>
<p>&nbsp;</p>
<ul>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg1n68-02Nov2012-Essential-Principles-of-Safety-Performance-of-Medical-Devices.pdf">Essential Principles of Safety &amp; Performance of Medical Devices GHTF/SG1/N68:2012</a></strong> supersedes GHTF/SG1/N41:2005</span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg1n78-02Nov2012-Principles-of-Conformity-Assessment-for-Medical-Devices.pdf">Principles of Conformity Assessment for Medical Devices GHTF/SG1/N78:2012</a></strong> supersedes GHTF/SG1/N40:2006</span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg1n77-02Nov2012-Principles-of-Medical-Devices-Classification.pdf">Principles of Medical Devices Classification GHTF/SG1/N77:2012</a></strong> supersedes GHTF/SG1/N15:2006</span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg3n19-02Nov2012-Quality-Management-System-Medical-Devices-Nonconformity-Grading-System-for-Regulatory-Purposes-Information-Exchange.pdf">Quality Management System &#8211; Medical Devices &#8211; Nonconformity Grading System for Regulatory Purposes &amp; Information Exchange GHTF/SG3/N19:2012</a></strong></span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg5n8-02Nov2012-Clinical-Evidence-for-IVD-Medical-Devices-Clinical-Performance-Studies-for-In-Vitro-Diagnostic-Medical-Devices.pdf">Clinical Evidence for IVD Medical Devices &#8211; Clinical Performance Studies for In Vitro Diagnostic Medical Devices GHTF/SG5/N8:2012 </a></strong></span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg5n7-02Nov2012-Clinical-Evidence-for-IVD-Medical-Devices-Scientific-Validity-Determination-Performance.pdf">Clinical Evidence for IVD Medical Devices &#8211; Scientific Validity Determination &amp; Performance GHTF/SG5/N7:2012</a></strong></span></li>
<li><span><strong><a href="http://www.eisnersafety.com/wp-content/uploads/2012/11/sg5n6-02Nov2012-Clinical-Evidence-for-IVD-Medical-Devices-Key-Definitions-Concepts.pdf">Clinical Evidence for IVD Medical Devices &#8211; Key Definitions &amp; Concepts GHTF/SG5/N6:2012</a></strong></span></li>
</ul>
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			</item>
		<item>
		<title>UK MHRA Revamped Website!</title>
		<link>https://eisnersafety.com/2012/01/18/uk-mhra-revamped-website/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=uk-mhra-revamped-website</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Wed, 18 Jan 2012 05:00:41 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Active Implantable Medical Devices Directive]]></category>
		<category><![CDATA[AIMDD]]></category>
		<category><![CDATA[Boderline Documents]]></category>
		<category><![CDATA[Classification]]></category>
		<category><![CDATA[Competent Authority]]></category>
		<category><![CDATA[conformity assessment]]></category>
		<category><![CDATA[EU]]></category>
		<category><![CDATA[Guidance Documents]]></category>
		<category><![CDATA[IVD]]></category>
		<category><![CDATA[legislation]]></category>
		<category><![CDATA[MDD]]></category>
		<category><![CDATA[MDD Amendment]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Directive]]></category>
		<category><![CDATA[Medical Device Industry]]></category>
		<category><![CDATA[Medical Device Regulatory]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[Medicinals]]></category>
		<category><![CDATA[medicines]]></category>
		<category><![CDATA[MHRA]]></category>
		<category><![CDATA[Notified Body]]></category>
		<category><![CDATA[regulatory news]]></category>
		<category><![CDATA[UK MHRA]]></category>
		<category><![CDATA[Vigilance]]></category>
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					<description><![CDATA[The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a]]></description>
										<content:encoded><![CDATA[<p style="text-align: left;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.mhra.gov.uk/index.htm">The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site!</a></span></p>
<p style="text-align: left;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, &amp; AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation &amp; guidance documents and more…</span></p>
<p style="text-align: left;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">If you are looking for information on Medical Devices under the MDD this is a <a href="http://www.mhra.gov.uk/Howweregulate/Devices/index.htm">good link to look at</a> for lots of information on the subject.</span></p>
<p style="text-align: left;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">If you are looking for information on Medicines legislation &amp; directives this is a <a href="http://www.mhra.gov.uk/Howweregulate/Medicines/index.htm">good link to look at</a> for lots of information on the subject.</span></p>
<p style="text-align: left;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">They even set-up a page for <a href="http://www.mhra.gov.uk/Howweregulate/NewTechnologiesForums/index.htm">New Technologies Forums</a> for both Medicines and Medical Devices.</span></p>
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