{"id":3678,"date":"2014-03-08T00:11:18","date_gmt":"2014-03-08T00:11:18","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3678"},"modified":"2014-03-08T00:11:18","modified_gmt":"2014-03-08T00:11:18","slug":"mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/03\/08\/mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012\/","title":{"rendered":"MD&#038;DI Article &#8220;Collaboration Holds the Key to Clarity on EN ISO 14971:2012&#8221;"},"content":{"rendered":"<p>7 March 2014 &#8211; <strong><a href=\"http:\/\/www.mddionline.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">MD&amp;DI<\/a> <a href=\"http:\/\/bit.ly\/EN_ISO14971-2012_Consensus_Doc_in_process_with_NBRG\" target=\"_blank\" rel=\"noopener noreferrer\">article written by Leo Eisner<\/a><\/strong> of Eisner Safety Consultants about the confusion of the EU Harmonized Standard <strong><a href=\"http:\/\/webshop.ds.dk\/catalog\/documents\/M265310_attachPV.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971:2012 Annexes ZA, ZB, &amp; ZC<\/a><\/strong> that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives)\u00a0and what is being done to reduce the confusion.<\/p>\n<p><!--more-->The NBRG (Notified Body\u00a0Recommendation Group) Risk Management Working Group is working to put together a consensus document. \u00a0A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it. \u00a0<strong><a href=\"http:\/\/bit.ly\/EN_ISO14971-2012_Consensus_Doc_in_process_with_NBRG\" target=\"_blank\" rel=\"noopener noreferrer\">Read the article for more details<\/a><\/strong> and a post that\u00a0<strong><a href=\"http:\/\/bit.ly\/NBRGSurveyOnAnnexZ_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">links to the survey<\/a><\/strong>.<\/p>\n<p>Past posts on this subject include:<\/p>\n<ul>\n<li><strong><a href=\"http:\/\/bit.ly\/NBRGConsensusDocENISO14971-12Slides\" target=\"_blank\" rel=\"noopener noreferrer\">NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&amp;M West &#8217;14 Presentation<\/a><\/strong><\/li>\n<li><strong><a href=\"http:\/\/bit.ly\/NBRGSurveyOnAnnexZ_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">NBRG Call for Industry Participation &#8211; Survey Understanding Annex Z EN ISO 14971:2012<\/a><\/strong><\/li>\n<\/ul>\n<p>If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at\u00a0<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>).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>7 March 2014 &#8211; MD&amp;DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, &amp; ZC that amends the EN ISO 14971:2009 version of the standard<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[262,35,1137,1138,185,206,4,1158,20,739,265,266,149,957,32,1159,5,427],"class_list":["post-3678","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-en-iso-14971","tag-en-iso-149712012","tag-eu","tag-european-commission","tag-iso-14971","tag-iso-149712007","tag-ivd","tag-ivd-directive","tag-ivdd","tag-medical-device-directive","tag-medical-devices","tag-nbrg","tag-notified-body","tag-notified-body-recommendation-group","tag-risk-management","tag-team-nb"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3678","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3678"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3678\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3678"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3678"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3678"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}