{"id":8699,"date":"2025-06-23T06:06:02","date_gmt":"2025-06-23T06:06:02","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8699"},"modified":"2025-08-18T16:51:29","modified_gmt":"2025-08-18T16:51:29","slug":"qmsr-microlearning-videos","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/","title":{"rendered":"QMSR Microlearning Videos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8699\" class=\"elementor elementor-8699\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0a79254 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0a79254\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5afc3b8\" data-id=\"5afc3b8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-ca7eb3b elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2025\/06\/23\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJune 23, 2025\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color: transparent;\">Navigating the FDA\u202fQMSR Transition: Insights for Compliance<\/span><\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"200\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2025\/06\/QMSR-Transition-Timeline-300x200.png\" class=\"attachment-medium size-medium wp-image-8757\" alt=\"QSR to QMSR Transition\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2025\/06\/QMSR-Transition-Timeline-300x200.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2025\/06\/QMSR-Transition-Timeline-500x334.png 500w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2025\/06\/QMSR-Transition-Timeline.png 768w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e30f3e6 elementor-widget elementor-widget-text-editor\" data-id=\"e30f3e6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>(5-Part Microlearning Video Series)<\/p><p><b>Audience:<\/b> Medical device professionals, quality managers, and compliance teams<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-07ed9d1 elementor-widget elementor-widget-heading\" data-id=\"07ed9d1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why You Should Care (Yes, You)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90940ab elementor-widget elementor-widget-text-editor\" data-id=\"90940ab\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tFDA just swapped out its 25-year-old Quality System Regulation (QSR) for the snazzy, ISO 13485-based Quality Management System Regulation (QMSR). The final rule dropped on <b>January 31, 2024<\/b>, and the clock is ticking toward <b>full enforcement on February 2, 2026<\/b> \u2013 that\u2019s a two-year timeframe and not a day more. Miss that deadline and you\u2019ll be explaining yourself to an FDA investigator faster than you can say \u201cForm\u202f483.\u201d\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5504a65 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5504a65\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/vimeo.com\/showcase\/11706488\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Click here for the full QMSR video series<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1432f44 elementor-widget elementor-widget-heading\" data-id=\"1432f44\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Video 1 \u2013 From QSR to QMSR: What\u2019s Changing and Why It Matters<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Watch time:<\/strong> 3\u202fmin<\/p><p><strong>In this video<\/strong><\/p><ul><li><strong>What is QMSR?<\/strong> A wholesale rewrite of 21 CFR Part 820 aligning US CGMP with ISO 13485:2016\u2014plus a few FDA-specific tweaks to keep lawyers happy.<\/li><li><strong>Why ISO 13485?<\/strong> Harmonization eliminates duplicate audits, smooths global market entry, and lets FDA leverage an already mature standard.<\/li><li><strong>Timeline you can\u2019t ignore:<\/strong><ul><li>Final rule published \u2013 <strong>31\u202fJan\u202f2024<\/strong><\/li><li>Effective date \u2013 <strong>2 Feb 2026<\/strong> (two-year implementation)<\/li><li>Your action plan: gap analysis \u2192 remediation \u2192 internal audits \u2192 management review \u2192 sleep better at night<\/li><\/ul><\/li><\/ul><p><strong>Pro tip:<\/strong> Start training ops and suppliers now\u2014nobody ever complained that they were \u201ctoo ready\u201d for an FDA inspection.<\/p><p>\u00a0<\/p><p><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/1058272506\" width=\"640\" height=\"360\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><br \/><\/iframe><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a40f8c elementor-widget elementor-widget-heading\" data-id=\"1a40f8c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Video 2 \u2013 QMSR Structure & Compliance<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b58bbf9 elementor-widget elementor-widget-text-editor\" data-id=\"b58bbf9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Watch time:<\/strong> 3\u202fmin<\/p><p><strong>In this video<\/strong><\/p><table><thead><tr><th>What Changed<\/th><th>Why It Matters<\/th><\/tr><\/thead><tbody><tr><td><b>Structure swapped<\/b> from subpart-heavy QSR to ISO 13485 clause order<\/td><td>Your QMS manual can finally look the same on both sides of the Atlantic<\/td><\/tr><tr><td><b>Risk-based thinking baked in<\/b><\/td><td>FDA expects risk management throughout the product life cycle, not bolted on at the end<\/td><\/tr><tr><td><b>Supplemental provisions<\/b> (complaint handling, traceability, servicing)<\/td><td>These FDA-only add-ons keep \u201cUS market\u201d nuances intact<\/td><\/tr><tr><td><b>Terminology update<\/b> (e.g., \u201cdevice master record\u201d \u2248 ISO\u2019s \u201cmedical device file\u201d)<\/td><td>Less glossary juggling for global teams<\/td><\/tr><tr><td><b>Documentation flexibility<\/b><\/td><td>If ISO 13485 lets you, do it digitally, FDA will too \u2013 just keep those records easily retrievable<\/td><\/tr><\/tbody><\/table><p><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/1080269126\" width=\"640\" height=\"360\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><br \/><\/iframe><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6f0a12 elementor-widget elementor-widget-text-editor\" data-id=\"b6f0a12\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>5-Step Action Checklist<\/strong><\/p><ol><li><strong>Gap analysis<\/strong> \u2013 Map every ISO\u202f13485 clause (and FDA extras) to your current procedures<\/li><li><strong>Risk files refresh<\/strong> \u2013 Align with ISO\u202f14971; regulators read ISO 13485 and ISO 14971 side by side<\/li><li><strong>Supplier requalification<\/strong> \u2013 Ignorance isn&#8217;t bliss; suppliers are in scope.<\/li><li><strong>Training blitz<\/strong> \u2013 Quality isn\u2019t a silo sport \u2013 get ops, RA\/QA, and exec teams speaking QMSR<\/li><li><strong>Mock FDA audit<\/strong> \u2013 Fix the warts while the lights are off<\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0162e79 elementor-widget elementor-widget-heading\" data-id=\"0162e79\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Video 3 \u2013 QMSR Risk Management Requirements<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-366cb52 elementor-widget elementor-widget-text-editor\" data-id=\"366cb52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Watch time:<\/strong> 2\u202fmin<\/p><p><strong>In this video<\/strong><\/p><p><strong>What you need to know<\/strong><br \/>Risk management is no longer just a design-phase requirement \u2013 under QMSR and ISO 13485, it must be integrated across the entire product life cycle. Learn what this shift means and how to stay compliant by 2026.<\/p><p>As FDA transitions from QSR to QMSR, risk management is no longer just a box to check during design; it must be embedded throughout the entire product life cycle.<\/p><p>This video breaks down what this shift means, how ISO 13485 and ISO 14971 factor in, and what steps manufacturers need to take to stay compliant by 2026.<\/p><p><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/1094079900\" width=\"640\" height=\"360\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><br \/><\/iframe><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c93703a elementor-widget elementor-widget-heading\" data-id=\"c93703a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Video 4 \u2013 Preparing for QMSR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-588e739 elementor-widget elementor-widget-text-editor\" data-id=\"588e739\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Watch time:<\/strong> 2\u202fmin<\/p><p><strong>In this video<\/strong><\/p><p><strong>Are you ready for the new records requirements in QMSR?<\/strong><br \/>If you&#8217;re still thinking it&#8217;s just business as usual, think again. The updated regulation introduces new expectations around:<\/p><p>\u00a0<\/p><ul><li>Complaint and servicing records<\/li><li>UDI inclusion in multiple record types<\/li><li>Confidentiality markings for FDA submissions<\/li><\/ul><p>These changes aren&#8217;t just technical updates \u2013 they&#8217;re strategic. Marking records as confidential helps protect your proprietary info. Including UDI across documents improves traceability. And is it ready for the inspection? That\u2019s non-negotiable.<br \/>\u00a0<\/p><ul><li>Continuous compliance isn\u2019t optional<\/li><li>Being prepared can make or break your next inspection<\/li><\/ul><p>\u00a0<\/p><p><strong>Navigate QMSR with clarity, not confusion.<\/strong> Let\u2019s get the inspection ready together.<\/p><p><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/1103529324\" width=\"640\" height=\"360\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" data-gtm-yt-inspected-15=\"true\" data-gtm-yt-inspected-20=\"true\" data-ready=\"true\"><br \/><\/iframe><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ac173b elementor-widget elementor-widget-heading\" data-id=\"4ac173b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Video 5 \u2013 QMSR \u2013 Process Meets Control<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0fc6180 elementor-widget elementor-widget-text-editor\" data-id=\"0fc6180\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Watch time:<\/strong> 2\u202fmin<\/p><p><strong>In this video<\/strong><\/p><p><strong>How do process thinking and risk controls drive better quality systems?<\/strong><br \/>In our latest video, we break down two core pillars of QMSR (Quality Management System Regulation) for medical devices: the <strong>process approach<\/strong> and <strong>risk-based controls<\/strong>.<\/p><p>You&#8217;ll learn how the <strong>PDCA cycle<\/strong> helps teams plan, execute, and improve processes, and how <strong>risk-based thinking<\/strong> ensures consistency, accuracy, and regulatory alignment.<\/p><p>Whether you&#8217;re in quality, regulatory, or operations, this is a quick, clear look at what makes a QMS truly effective.<\/p><p>Watch now to see how these concepts come together for stronger compliance and smarter systems.<\/p><p><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/1098187535\" width=\"640\" height=\"360\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" data-gtm-yt-inspected-15=\"true\" data-gtm-yt-inspected-20=\"true\" data-ready=\"true\"><br \/><\/iframe><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37606e5 elementor-widget elementor-widget-heading\" data-id=\"37606e5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Keep the Conversation Going<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27f723d elementor-widget elementor-widget-text-editor\" data-id=\"27f723d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tWe invite you and your team to register for one of these courses offered by ELIQUENT Life Sciences for in-depth expansion:\n<ul>\n \t<li><a href=\"https:\/\/www.orielstat.com\/coursedetailnew.aspx?mpgid=16&amp;pgid=16&amp;cpaid=3&amp;cspaid=4&amp;courseid=302\">Transition from the FDA\u2019s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR)<\/a> \u2013 DaySmart Series<\/li>\n \t<li><a href=\"https:\/\/www.orielstat.com\/coursedetailnew.aspx?mpgid=16&amp;pgid=16&amp;cpaid=3&amp;cspaid=4&amp;courseid=307\">QMS Training for Medical Devices: ISO 13485:2016 and US FDA QMSR<\/a><\/li>\n<\/ul>\nIf you find the videos helpful, share this post with a colleague who\u2019s still clinging to the old QSR like it\u2019s vinyl in a Spotify world. <em>Because February\u202f2026 will arrive whether your CAPA log is ready or not.<\/em>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Navigating the FDA\u202fQMSR Transition: Insights for Compliance (5-Part Microlearning Video Series) Audience: Medical device professionals, quality managers, and compliance teams Why You Should Care (Yes, You) FDA just swapped out its 25-year-old Quality System Regulation (QSR) for the snazzy, ISO 13485-based Quality Management System Regulation (QMSR). The final rule dropped on January 31, 2024, and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6213,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Navigating the FDA\u202fQMSR Transition: Insights for Compliance (5-Part Microlearning Video Series) Audience: Medical device professionals, quality managers, and compliance teams Why You Should Care (Yes, You) FDA just swapped out its 25-year-old Quality System Regulation (QSR) for the snazzy, ISO 13485-based Quality Management System Regulation (QMSR). 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The final rule dropped on January 31, 2024, and [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2025-06-23T06:06:02+00:00","article_modified_time":"2025-08-18T16:51:29+00:00","og_image":[{"width":2048,"height":842,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/06\/qmsdigital.jpeg","type":"image\/jpeg"}],"author":"Oriel STAT A MATRIX","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Oriel STAT A MATRIX","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/"},"author":{"name":"Oriel STAT A MATRIX","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/c137edf93eeddb244b6098bf8d2e09ed"},"headline":"QMSR Microlearning Videos","datePublished":"2025-06-23T06:06:02+00:00","dateModified":"2025-08-18T16:51:29+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/"},"wordCount":826,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["EU MDR (2017\/745)"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/","url":"https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2025-06-23T06:06:02+00:00","dateModified":"2025-08-18T16:51:29+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/qmsr-microlearning-videos\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/c137edf93eeddb244b6098bf8d2e09ed","name":"Oriel STAT A MATRIX","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/5362548f38f456fa69cbc3bb0c9f1a96?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/5362548f38f456fa69cbc3bb0c9f1a96?s=96&d=mm&r=g","caption":"Oriel STAT A MATRIX"},"url":"https:\/\/www.orielstat.com\/blog\/author\/orielstat\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8699"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=8699"}],"version-history":[{"count":31,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8699\/revisions"}],"predecessor-version":[{"id":8762,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8699\/revisions\/8762"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/6213"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=8699"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=8699"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=8699"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}