{"id":3611,"date":"2014-01-31T21:29:34","date_gmt":"2014-01-31T21:29:34","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3611"},"modified":"2014-01-31T21:29:34","modified_gmt":"2014-01-31T21:29:34","slug":"leo-eisner-track-chair-at-mdm-west-conf-11-feb-discuss-en-iso-149712012","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/01\/31\/leo-eisner-track-chair-at-mdm-west-conf-11-feb-discuss-en-iso-149712012\/","title":{"rendered":"Leo Eisner Track Chair at MD&#038;M West Conf 11-Feb Discuss EN ISO 14971:2012"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">UBM Canon Communications has graciously asked me to join this year&#8217;s <strong><a href=\"http:\/\/www.canontradeshows.com\/expo\/west14\/\" target=\"_blank\" rel=\"noopener noreferrer\">MD&amp;M West<\/a><\/strong>\u00a0Conference with the honor of being the track chair for the <strong><a href=\"http:\/\/www.canontradeshows.com\/expo\/west14\/conference-agenda-quality.html\" target=\"_blank\" rel=\"noopener noreferrer\">Risk, Quality &amp; Validation track on\u00a0Tues 11 Feb 2014<\/a><\/strong>. \u00a0We have a great line up that day so please come join us. \u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">To kick-off the morning for our track I will be talking briefly on a draft document that NB-MED &amp; COCIR &amp; some other organizations are working on to help clarify what is expected of medical device manufacturers when relying on EN ISO 14971:2012 which is a document that has totally muddied the waters.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> <!--more-->I am in direct contact with the authors of this consensus based document and we are working on finalizing what I will be presenting to you at\u00a0<\/span><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">the conference. So, expect some up to the date information about this document and we may be asking for feedback from industry too. \u00a0Stay tuned for any updates to this post too. \u00a0I look forward to presenting this material to the conference participants.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">If you need help with the Risk Management File concepts within 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. Leo 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>\n","protected":false},"excerpt":{"rendered":"<p>UBM Canon Communications has graciously asked me to join this year&#8217;s MD&amp;M West\u00a0Conference with the honor of being the track chair for the Risk, Quality &amp; Validation track on\u00a0Tues 11 Feb 2014. \u00a0We have a great line up that day<\/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":[1156,15,59,1136,1137,1138,27,218,4,1143,1157],"class_list":["post-3611","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-1156","tag-60601-1","tag-60601-1-3rd-ed-amendment-1","tag-en-60601-106-amendment-113","tag-en-iso-14971","tag-en-iso-149712012","tag-escnews","tag-iec-60601-1","tag-iso-14971","tag-risk-management-process","tag-risk-management-standard"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3611","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=3611"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3611\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}