{"id":5074,"date":"2017-03-15T23:39:32","date_gmt":"2017-03-15T23:39:32","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=5074"},"modified":"2022-06-12T18:23:26","modified_gmt":"2022-06-12T18:23:26","slug":"medical-compliance-seminar-may-18-17-toronto-canada","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2017\/03\/15\/medical-compliance-seminar-may-18-17-toronto-canada\/","title":{"rendered":"Medical Compliance Seminar May 18, &#8217;17  &#8211; Toronto, Canada"},"content":{"rendered":"<h4><a href=\"https:\/\/www.eisnersafety.com\/eisnersafetycom\/\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-5966 size-full\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/logo-medium.png\" alt=\"\" width=\"95\" height=\"200\"><\/a>MEDICAL COMPLIANCE SEMINAR<\/h4>\n<h6>Thursday, May 18, 2017<\/h6>\n<p><a href=\"http:\/\/www.tuv-sud.ca\" target=\"_blank\" rel=\"attachment noopener wp-att-5103 noreferrer\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-5103\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/TUV-Canada-logo-266x300-1.jpg\" alt=\"TUV Canada logo\" width=\"79\" height=\"89\"><\/a><\/p>\n<h5>Seminar Topics:<\/h5>\n<ul>\n<li><strong>Current guidance around Medical Electrical Equipment for FDA 510(k)s &amp;&nbsp;Health Canada<\/strong><\/li>\n<li><strong>IEC 60601-1 series:<\/strong>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Intro to IEC 60601 -1 series with Collateral &amp; Particular Standards<\/li>\n<li>Design &amp; compliance to IEC 60601-1 3rd edition (including AM1)<\/li>\n<li>Changes to the 60601-1 series and supporting standards: Updates on what\u2019s new and draft documents that may impact your&nbsp;Compliance strategy<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li><strong>ISO 14971:2007 Risk Management File (RMF) Overview<\/strong><\/li>\n<\/ul>\n<p>See the <a href=\"#Seminar_Agenda\">detailed Seminar Agenda<\/a>.<\/p>\n<p>Sign-up for Workshop Closed<\/p>\n<h5>Bio&#8217;s of Presenters<\/h5>\n<p><b>Leo Eisner<\/b>, principal medical device product safety &amp; regulatory consultant of Eisner Safety Consultants.<br \/>\nLeo\u2019s firm specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. He has been called the \u201cIEC 60601-1 Guy\u201d by his clients and associates. Leo\u2019s focus is on active medical electrical equipment including home use and wearable devices. Leo is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC&nbsp;SC62D JWG9 (IEC\/ISO80601-2-58) &amp; a committee member of US TAG for TC62, SC62A, SC62D, &amp; SyC&nbsp;AAL (Active Assisted Living System Committee &#8211; Home use medical and non-medical devices). Leo is a registered professional engineer in safety and has over 30 years experience in product safety. Leo is a&nbsp;member of RAPS, AAMI, ASQ, &amp; IEEE. He\u2019s manager of the LinkedIn discussion group IEC 60601 Series \u2013 Medical Electrical Equipment.<\/p>\n<p><b>Peter Keith<\/b> P.Eng, Senior Engineer and Technical Certifier at T\u00dcV S\u00dcD Canada Inc.<br \/>\nPeter is the lead medical services engineer at T\u00dcV S\u00dcD Canada with 10 + years of safety evaluation and regulatory experience, specializing in safety certification of medical and laboratory equipment such as hospital beds, ECGs, therapeutic lights, TENS, Lasers and more. Peter has participated on technical committees such as CACES (Canadian Advisory Committee on Electrical Safety) and assisted on the&nbsp;development of CSA SPE &#8211; 3000:2015. Peter is a licensed professional Engineer in Ontario and has evaluated over 400 medical and laboratory projects and given various seminars on regulatory and standards compliance.<\/p>\n<hr>\n<p><b><a name=\"Seminar_Agenda\"><\/a>Seminar Agenda:<\/b><\/p>\n<p>Meet and Greet (9:00 AM)<\/p>\n<p>Introduction to T\u00dcV S\u00dcD Canada &amp; Presenter\u2019s Backgrounds (9:15 AM)<\/p>\n<p>Current US &amp; Canadian Guidance for Medical Electrical Equipment<br \/>\n(9:30 to 10:45 AM)<\/p>\n<p>Break time (15 Minutes)<\/p>\n<p>Intro to IEC 60601-1 series (11:00 to 12:00 PM)<\/p>\n<p>Q &amp; A for Morning Session (12:00 \u2013 12:15 PM)<\/p>\n<p>Break for Lunch (lab tour and test demo) (12:15 to 1:30 PM)<\/p>\n<p>Design and Compliance to 60601 \u2013 1 3rd edition (1:30 to 2:30 PM)<\/p>\n<p>Upcoming Standards Changes and Updates Related to 60601 Series<br \/>\n(2:30 to 3:30 PM)<\/p>\n<p>Break time (15 Minutes)<\/p>\n<p>ISO 14971:2007 Risk Management File (RMF) Overview (3:45 \u2013 4:45 PM)<\/p>\n<p>Q &amp; A<\/p>\n","protected":false},"excerpt":{"rendered":"<p>MEDICAL COMPLIANCE SEMINAR Thursday, May 18, 2017 Seminar Topics: Current guidance around Medical Electrical Equipment for FDA 510(k)s &amp;&nbsp;Health Canada IEC 60601-1 series: Intro to IEC 60601 -1 series with Collateral &amp; Particular Standards Design &amp; compliance to IEC 60601-1<\/p>\n","protected":false},"author":4,"featured_media":6501,"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":[1],"tags":[15,275,9,370,100,1184,218,692,1319],"class_list":["post-5074","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-60601-1","tag-cmdr","tag-fda","tag-guidance","tag-health-canada","tag-iec-60601-series","tag-iec-60601-1","tag-iec-60601-1-edition-3-1","tag-standards-updates"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5074","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=5074"}],"version-history":[{"count":9,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5074\/revisions"}],"predecessor-version":[{"id":6662,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5074\/revisions\/6662"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6501"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=5074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=5074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=5074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}