<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Post-market – Eisner Safety Consultants</title> <atom:link href="https://eisnersafety.com/tag/post-market/feed/" rel="self" type="application/rss+xml" /> <link>https://eisnersafety.com</link> <description>Just another WordPress site</description> <lastBuildDate>Sat, 31 May 2014 19:35:45 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7.1</generator> <item> <title>BSI White Paper on Generating Clinical Evaluation Reports</title> <link>https://eisnersafety.com/2014/05/31/bsi-white-paper-on-generating-clinical-evaluation-reports/?utm_source=rss&utm_medium=rss&utm_campaign=bsi-white-paper-on-generating-clinical-evaluation-reports</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sat, 31 May 2014 19:35:45 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[BSI]]></category> <category><![CDATA[Clinical]]></category> <category><![CDATA[Clinical evaluation]]></category> <category><![CDATA[Clinical Follow-up]]></category> <category><![CDATA[ESC]]></category> <category><![CDATA[ESC News]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU Regulation]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVDs]]></category> <category><![CDATA[MDD]]></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[Notified Body]]></category> <category><![CDATA[PMCF]]></category> <category><![CDATA[Post-market]]></category> <category><![CDATA[Post-market Clinical Follow-up]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3900</guid> <description><![CDATA[Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports White Paper on Generating clinical evaluation reports This white paper is on “Generating clinical evaluation reports – A guide]]></description> <content:encoded><![CDATA[<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><a href="http://www.eisnersafety.com/wp-content/uploads/2014/05/BSI_WP_ClinRprt_shareasimage1.png"><img fetchpriority="high" decoding="async" class="alignleft size-medium wp-image-3915" style="margin-top: -2px; margin-bottom: -2px;" title="BSI_WP_ClinRprt" src="http://www.eisnersafety.com/wp-content/uploads/2014/05/BSI_WP_ClinRprt_shareasimage1-211x300.png" alt="" width="211" height="300" /></a>Blog focus BSI’s 2<sup>nd</sup> in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports</span></p> <h2><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong>White Paper on Generating clinical evaluation reports</strong><strong></strong></span></h2> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">This white paper is on “<strong><a title="Click here to link to the White Paper once you sign up on BSI's web page" href="http://www.bsigroup.com/en-GB/our-services/medical-device-services/BSI-Medical-Devices-Whitepapers/?utm_source=PM-SUB-LAU-BSOL-Whitepaper2-USMAXPROENG-1405&utm_medium=et_mail&utm_content=3728082&utm_campaign=%25%25email%20name%25%25&utm_term=Whitepaper2ABUTT" target="_blank" rel="noopener noreferrer">Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance</a></strong>” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).” It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, <strong><a href="http://medicaldevices.bsigroup.com/">BSI</a></strong> .</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.<br /> <span id="more-3900"></span></span></p> <h2><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong>White Paper Series and Future Topics to Come</strong><strong></strong></span></h2> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">The additional white papers in the series will be on:</span></p> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">The digital patient</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Post-market surveillance</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Usability engineering</span></li> </ul> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.bsigroup.com/en-GB/our-services/medical-device-services/BSI-Medical-Devices-Whitepapers/" target="_blank" rel="noopener noreferrer">You can sign-up for the whole series of white papers too</a></strong> (further down the webpage on BSI’s website). </span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</span></p> ]]></content:encoded> </item> </channel> </rss>