{"id":4251,"date":"2020-02-06T07:45:29","date_gmt":"2020-02-06T07:45:29","guid":{"rendered":"https:\/\/lorit-consultancy.com\/2020\/02\/iec-60601-1-advanced-course-keep-the-finger-on-the-pulse\/"},"modified":"2022-09-26T15:49:06","modified_gmt":"2022-09-26T13:49:06","slug":"iec-60601-1-advanced-course-keep-the-finger-on-the-pulse","status":"publish","type":"post","link":"https:\/\/lorit-consultancy.com\/en\/2020\/02\/iec-60601-1-advanced-course-keep-the-finger-on-the-pulse\/","title":{"rendered":"IEC 60601-1 Advanced Course: Keep the finger on the pulse"},"content":{"rendered":"<p>The development of medical devices is driven by risk identification and mitigation.<\/p>\n<p>Let\u00b4s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as <a href=\"https:\/\/lorit-consultancy.com\/en\/standards\/medical-devices\/iec60601\/\" target=\"_blank\" rel=\"noopener\">IEC 60601<\/a> and its particular standard 60601-2-4 is a major challenge. Through the whole development process, <strong>it is key to identify potential risks<\/strong> in the device, in systems, hardware and software to be successful in the market and at the end of the day to save lives.<\/p>\n<p>For that reason and because compliance is a requirement for most markets every company needs experienced engineers who know how to <strong>implement, maintain and work with the IEC 60601<\/strong> series of standards.<\/p>\n<h2><strong>Our experience<\/strong><\/h2>\n<p>The\u00a0<a href=\"https:\/\/lorit-consultancy.com\/en\/our-team\/\">Lorit Consultancy Team<\/a>\u00a0has many years of experience in software and hardware development in various industries. Since 2014 we are working as\u00a0<a href=\"https:\/\/lorit-consultancy.com\/en\/about-us\/\">consultants<\/a>\u00a0and\u00a0<a href=\"https:\/\/lorit-consultancy.com\/en\/training\/\">trainers<\/a>\u00a0on functional safety related projects. With our broad experience in <strong>risk management and regulatory compliance<\/strong>, we assist you in ensuring that your medical devices fulfil the safety requirements defined in IEC 60601-1 and many other standards.<\/p>\n<div id='gallery-1' class='gallery galleryid-4251 gallery-columns-2 gallery-size-thumbnail'><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<a href='https:\/\/lorit-consultancy.com\/wp-content\/uploads\/2020\/02\/30-IMG_0285-scaled.jpg'><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"640\" src=\"https:\/\/lorit-consultancy.com\/wp-content\/uploads\/2020\/02\/30-IMG_0285-640x640.jpg\" class=\"attachment-thumbnail size-thumbnail\" alt=\"\" \/><\/a>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<a href='https:\/\/lorit-consultancy.com\/wp-content\/uploads\/2020\/02\/30-IMG_0419-scaled.jpg'><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"640\" src=\"https:\/\/lorit-consultancy.com\/wp-content\/uploads\/2020\/02\/30-IMG_0419-640x640.jpg\" class=\"attachment-thumbnail size-thumbnail\" alt=\"\" \/><\/a>\n\t\t\t<\/div><\/figure>\n\t\t<\/div>\n\n<h2><strong>Advanced course for enhancing your risk management<\/strong><\/h2>\n<p>Our aim is to support our clients to get a clear understanding of the safety standards in the medical device sector and enable them <strong>to successfully comply with regulatory approvals.<\/strong> We recently set up an additional course for the medical device industry. Beside our existing\u00a0IEC 60601-1 Introductory course we are now offering an IEC 60601-1 Advanced course.<\/p>\n<p><strong>The course focuses on:<\/strong><\/p>\n<ul>\n<li>System, hardware and software architecture<\/li>\n<li>Expanding the concepts of Programmable Medical Electrical Systems (PEMS) section 14<\/li>\n<li>Many practical examples of essential performance, risk control and basic safety for a variety of products<\/li>\n<li>Quantitative risk analysis<\/li>\n<li>Inductive and deductive risk management techniques such as Fault Tree Analysis (FTA) and Failure Mode and Effects Criticality Analysis (FMECA)<\/li>\n<li>Considerations for safety critical products and the relationship to IEC 62304<\/li>\n<li>A detailed overview of the challenges for ME Systems<\/li>\n<li>EMC challenges in complying with IEC 60601-1-2<\/li>\n<\/ul>\n<p><strong>To book this course or discuss customised training, please take a look at our <a href=\"https:\/\/lorit-consultancy.com\/en\/training\/\" target=\"_blank\" rel=\"noopener\">training page<\/a> or email us at <a href=\"mailto:info@lorit-consultancy.com\">info@lorit-consultancy.com<\/a> or call us on +44 7708 360023 or +43 676 338 8884.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The development of medical devices is driven by risk identification and mitigation. Let\u00b4s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as IEC 60601 and its particular standard 60601-2-4 is a major challenge. Through the whole development process, it is key to identify potential [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":3853,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[87,92,98],"tags":[],"class_list":["post-4251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-functional-safety","category-medical-devices","category-training"],"acf":[],"_links":{"self":[{"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/posts\/4251","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/comments?post=4251"}],"version-history":[{"count":6,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/posts\/4251\/revisions"}],"predecessor-version":[{"id":5459,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/posts\/4251\/revisions\/5459"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/media\/3853"}],"wp:attachment":[{"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/media?parent=4251"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/categories?post=4251"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lorit-consultancy.com\/en\/wp-json\/wp\/v2\/tags?post=4251"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}