{"id":7641,"date":"2024-08-29T16:47:52","date_gmt":"2024-08-29T16:47:52","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7641"},"modified":"2024-08-30T16:28:35","modified_gmt":"2024-08-30T16:28:35","slug":"free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2024\/08\/29\/free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey\/","title":{"rendered":"Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/08\/LondonMarketign-Logo-Post-26Aug2024.png\" alt=\"\" class=\"wp-image-7652\" width=\"1219\" height=\"1065\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/08\/LondonMarketign-Logo-Post-26Aug2024.png 936w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/08\/LondonMarketign-Logo-Post-26Aug2024-300x262.png 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/08\/LondonMarketign-Logo-Post-26Aug2024-768x671.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/08\/LondonMarketign-Logo-Post-26Aug2024-600x524.png 600w\" sizes=\"auto, (max-width: 1219px) 100vw, 1219px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><span style=\"text-decoration: underline;\">What\u2019s on the menu\ud83c\udf70?<\/span><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Where are we headed with 4th Ed.?<br>Structure changes; <br>Project timeline: and <br>Critical documents<br><br><a href=\"https:\/\/bit.ly\/LeoEisnerLinkedInProfile\" target=\"_blank\" rel=\"noreferrer noopener\">Leo Eisner<\/a>, the \u201cIEC 60601 Guy\u201d, of Eisner Safety Consultants will be your guide<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">What to do in the meantime? <br>Select applicable and normative standards for testing; and<br>How to set up a solid future-proof test plan<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IanSealeyLIProfile\" target=\"_blank\">Ian Sealey<\/a> of Vertexian will explain it<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"text-decoration: underline;\"><strong>When, Where, How:<\/strong><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">7 October 2024<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a rel=\"noreferrer noopener\" href=\"https:\/\/www.claytonhotels.com\/chiswick\/\" target=\"_blank\">Clayton Hotel Chiswick<\/a><br>Arrive 5:00 PM<br>Starts 5:30 PM<br>Ends 8:45 PM<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Networking and meet for drinks afterwards<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Register by either using our <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/ContactUsESC\" target=\"_blank\">Contact form<\/a> or send Leo a <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/LeoEisnerLinkedInProfile\" target=\"_blank\">LinkedIn message via his profile<\/a>.  <\/p>\n\n\n\n<blockquote class=\"wp-block-quote has-text-align-left is-style-large is-layout-flow wp-block-quote-is-layout-flow\" style=\"font-style:normal;font-weight:700\"><p><strong>If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.<\/strong><\/p><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><span style=\"text-decoration: underline;\"><strong>Presenters Background:<\/strong><\/span><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/bit.ly\/LeoEisnerLinkedInProfile\" target=\"_blank\" rel=\"noreferrer noopener\">Leo<\/a> is the <strong>founder and principal compliance and regulatory consultant<\/strong> of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME\u2019s to Fortune 500\u2019s) with product safety compliance &amp; regulatory support focused on:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>design for compliance to IEC 60601 series of standards;<\/li><li>design reviews against applicable requirements;<\/li><li>identification of applicable standards, laws, regulations, directives and guidances;<\/li><li>labeling reviews;<\/li><li>support with test labs;<\/li><li>training<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Leo\u2019s <strong>leadership<\/strong> <strong>and commitment<\/strong> in the <strong>standards development process<\/strong> <strong>runs deep<\/strong> and <strong>over many years<\/strong> including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years.&nbsp; <br>His IEC 60601-1, 4<sup>th<\/sup> edition involvement:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Co-Convener of <a rel=\"noreferrer noopener\" href=\"https:\/\/www.iec.ch\/dyn\/www\/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:49842,25\" target=\"_blank\">IEC\/TC 62\/SC 62A\/WG39<\/a> &#8211; User interface aspects<\/li><li>Advisory group member of <a rel=\"noreferrer noopener\" href=\"https:\/\/www.iec.ch\/dyn\/www\/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:50421,25\" target=\"_blank\">IEC\/TC 62\/SC 62A\/AG 50<\/a> &#8211; IEC 60601-1 Ed. 4.0 editing &amp; leadership team<\/li><li>Committee member <a rel=\"noreferrer noopener\" href=\"https:\/\/www.iec.ch\/dyn\/www\/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:49840,25\" target=\"_blank\">IEC\/SC 62A\/WG37<\/a> &#8211; General requirements<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">To see a more detailed list go to <a href=\"http:\/\/linkedin.com\/in\/leoeisnersafetyconsultants\" target=\"_blank\" rel=\"noreferrer noopener\">Leo\u2019s LinkedIn Profile<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IanSealeyLIProfile\" target=\"_blank\">Ian Sealey<\/a> is the <strong>founder of Vertexian and is a medical device regulatory and quality consultant<\/strong>, with over 25 years\u2019 experience. Vertexian provides the medtech industry with support in the following areas:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>electromedical devices;<\/li><li>risk management;<\/li><li>pre-compliance testing;<\/li><li>training;<\/li><li>UKCA marking; and<\/li><li>manufacture of IEC test equipment<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.<\/p>\n\n\n\n<pre class=\"wp-block-preformatted\"><\/pre>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.&nbsp;Eisner Safety Consultants&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/about_us\/associates\/\" target=\"_blank\">team of experts<\/a> also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more.&nbsp;He team includes experts on additional standards committees and we all talk to the regulators regularly. We&#8217;re here to support your needs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We work with many test labs for Medical Safety &amp; EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Feel free to&nbsp;<a rel=\"noreferrer noopener\" href=\"http:\/\/www.eisnersafety.com\/Schedule-Call\/\" target=\"_blank\">schedule a call with Leo<\/a>&nbsp;or contact Leo at&nbsp;Leo@EisnerSafety.com&nbsp;or through our&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/contact_eisner_safety\/\" target=\"_blank\">contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and More with Leo Eisner and Ian Sealey<\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><strong><span style=\"text-decoration: underline;\">What\u2019s on the menu\ud83c\udf70?<\/span><\/strong><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Where are we headed with 4th Ed.?<br \/>Structure changes; <br \/>Project timeline: and <br \/>Critical documents<\/p>\n<p>L<a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/LeoEisnerLinkedInProfile\" target=\"_blank\">eo Eisner<\/a>, the \u201cIEC 60601 Guy\u201d, of Eisner Safety Consultants will be your guide<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>What to do in the meantime? <br \/>Select applicable and normative standards for testing; and<br \/>How to set up a solid future-proof test plan<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IanSealeyLIProfile\" target=\"_blank\">Ian Sealey<\/a> of Vertexian will explain it<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><a href=\"https:\/\/www.claytonhotels.com\/chiswick\/\" target=\"_blank\" rel=\"noreferrer noopener\">Clayton Hotel Chiswick<\/a><br \/>Arrive 5:15 PM<br \/>Starts 5:30 PM sharp<br \/>Ends 8:45 PM<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Networking and meet for drinks afterwards<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n","protected":false},"author":4,"featured_media":7652,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1402,1425,1517,1386,1325,1350,1358,1353,1355,1354,1510,1397,1398,1403,1423,1526,1502,1539,1496,1520,1443,1493,1503,1445,1466,1410,1499,1394,1501,1528,1424,1518,1427,1540,1459,1512,1461,1497,1446,1521,1498,1508,1411,1444,1435,1391,1368,1438,1524,1527,1525],"tags":[15,1541,27,13,22,330,174,149],"class_list":["post-7641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1402","category-15223-1","category-1517","category-60601-series","category-60601-1","category-60601-1-11","category-60601-1-12","category-60601-1-2","category-60601-1-6","category-60601-1-8","category-60601-1-4th-edition","category-1397","category-1398","category-62366-1","category-aim-7351731","category-alarm-systems","category-architecture-specification","category-aug-2024","category-coexistence","category-combination-device","category-combination-product","category-cybersecurity","category-design-specification","category-device","category-emc","category-essential-performance","category-hazards","category-iec","category-iec-60601-1","category-information-provided-by-the-manufacturer","category-iso-15223-1","category-iso-20417","category-labeling","category-london","category-marking","category-mechanical","category-medical-device","category-pems","category-physiologic-closed-loop-control","category-risk-management","category-samd","category-simd","category-single-fault-condition","category-software","category-standards","category-standards-development","category-state-of-the-art","category-uk","category-usability","category-usability-engineering-process","category-user-interfaces","tag-60601-1","tag-60601-1-4th-ed","tag-escnews","tag-iec","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7641","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=7641"}],"version-history":[{"count":26,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7641\/revisions"}],"predecessor-version":[{"id":7671,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7641\/revisions\/7671"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7652"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7641"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7641"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7641"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}