{"id":8522,"date":"2025-03-31T22:07:38","date_gmt":"2025-03-31T22:07:38","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8522"},"modified":"2025-03-31T22:14:29","modified_gmt":"2025-03-31T22:14:29","slug":"less-than-a-year-qmsr-is-getting-closer","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/less-than-a-year-qmsr-is-getting-closer\/","title":{"rendered":"Less Than A Year to Go! FDA\u2019s New Quality Management System Regulation (QMSR) Is Getting Closer"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8522\" class=\"elementor elementor-8522\" 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 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-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2025\/03\/31\/\">\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\tMarch 31, 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\">Less Than A Year!  FDA's QMSR Is Getting Closer<\/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=\"2560\" height=\"1440\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-scaled.jpeg\" class=\"attachment-full size-full wp-image-5302\" alt=\"paper checklist with a black leaded pencil\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-300x169.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-1024x576.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-768x432.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-1536x864.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-2048x1152.jpeg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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-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<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><a href=\"https:\/\/www.federalregister.gov\/documents\/2022\/02\/23\/2022-03227\/medical-devices-quality-system-regulation-amendments\" target=\"_blank\" rel=\"nofollow noopener\">The new Quality Management System Regulation <\/a>(QMSR) \u2013 FDA\u2019s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 \u2013 is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin enforcing the QMSR requirements.<\/p><p>The major change coming for those organizations who fall within the scope of the Regulation is the \u201cincorporation by reference\u201d of the requirements of ISO 13485:2016 Medical devices\u2014Quality management systems\u2014Requirements for regulatory purposes. ISO 13485 was introduced in 1996, which happens to be the last time a major update to 21 CFR Part 820 (QSR) occurred. Since that time, ISO 13485 has been modified a few times, and the most recent version \u2013 ISO 13485:2016 \u2013 is very similar to FDA QSR. In fact, many people with knowledge of the QSR and ISO 13485:2016 talk about the two containing nearly the same requirements.<\/p><p>This incorporation of ISO 13485:2016 by reference in the QMSR makes the ISO 13485:2016 requirements the basis for quality system compliance for manufacturers of medical devices, in-vitro diagnostics, and combination products with a device constituent marketed in the US. This approach means that all companies required to comply with the QMSR will essentially be following ISO 13485:2016 \u2013 even if they are not certified to the standard by a third party.<\/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-ac24c49 elementor-widget elementor-widget-heading\" data-id=\"ac24c49\" 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\">What Should You Do First?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91e0879 elementor-widget elementor-widget-text-editor\" data-id=\"91e0879\" 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>Of course, first you should read the QMSR and become familiar with the new structure and content of 21 CFR Part 820. The entire Regulation has been replaced with a new structure in QMSR \u2013 it is not just a revision of the existing QSR with sections taken out or replaced.<\/p><p>You also need to make sure you understand the full requirements of ISO 13485:2016. Even though it is \u201csubstantially similar\u201d (in FDA\u2019s opinion), there are still details within the standard that are not included explicitly in the QSR today.<\/p><p>If you are new to ISO 13485:2016 and need a copy quickly, you can view the standard content online via the <a href=\"https:\/\/ibr.ansi.org\/Standards\">American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal<\/a>. However, this online version is a read-only format, and you must register on the site each time you wish to see the document \u2013 not very convenient for your day-to-day work. For longer-term use, you need to purchase the standard for your organization. Once you have the standard, read it through from beginning to end, including the introduction (Clause 0).<\/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-46b48d9 elementor-widget elementor-widget-heading\" data-id=\"46b48d9\" 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\">From FDA QSR to QMSR: Changes and Questions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed41b49 elementor-widget elementor-widget-text-editor\" data-id=\"ed41b49\" 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>One of the first questions you may have when you\u2019re looking through the ISO 13485:2016 requirements is about the phrase \u201capplicable regulatory requirements.\u201d That phrase is used throughout the standard to require organizations to identify all of the global regulatory requirements that are relevant to their organization\u2019s quality system. But if FDA is following this requirement, does that mean they will be asking you about how you meet the quality system requirements for all the countries where you market your devices? Fortunately, no. FDA has made it clear in QMSR 820.10(b) that the \u201capplicable regulatory requirements\u201d for FDA will be only other US regulations (e.g., 21 CFR Part 803 for reporting to regulatory authorities).<\/p><p>\u00a0<br \/>Check out <a href=\"https:\/\/www.orielstat.com\/blog\/fda-qsr-vs-qmsr\/\">our previous QMSR blog<\/a> that walks through the big changes from the QSR to the QMSR:<br \/>\u00a0<\/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-0caf1e6 elementor-widget elementor-widget-heading\" data-id=\"0caf1e6\" 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\">Audit vs. Inspection: How We Need to Shift Our Thinking About ISO 13485:2016 Requirements Under the QMSR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc6bf9 elementor-widget elementor-widget-text-editor\" data-id=\"3dc6bf9\" 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>Your QMS may be certified already in some way to the requirements of ISO 13485:2016 by a recognized auditing organization for MDSAP (Medical Device Single Audit Program), by a designated Notified Body as part of your conformity assessment for CE Marking in the EU, or by an accredited certification body for a stand-alone ISO 13485:2016 certification. All of these certifications are achieved through audits, but FDA will be doing regulatory inspections. The reality is that a regulatory authority inspection has a different objective and \u201cfeel\u201d than a certification audit.<\/p><p>For starters, an FDA inspection can be more thorough than an audit \u2013 remember, an FDA investigator is not limited by a contracted audit plan like the person who conducted your certification audit. If the investigator has identified potential issues with your QMS, they can extend the inspection (by days or even weeks) until they have collected the objective evidence needed to complete their assessment of your facility.<\/p><p>An FDA inspection also can have specific regulatory implications for your organization that you would not experience from a certification audit. If you are not meeting the QMSR requirements, FDA could use their available tools (warning letters, import alerts, injunctions, seizures, civil money penalties) to address the observed issues with your company.<\/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-fc2ca86 elementor-widget elementor-widget-text-editor\" data-id=\"fc2ca86\" 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>Taking all of this into consideration, everyone who is comfortable with their current ISO 13485:2016 QMS audits needs to assess how well their existing processes and documentation will fare under this different type of scrutiny.<\/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-ca3437e elementor-widget elementor-widget-heading\" data-id=\"ca3437e\" 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\">How Can We Help?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31a1563 elementor-widget elementor-widget-text-editor\" data-id=\"31a1563\" 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>If you are looking for more information related to the QMSR or the requirements of ISO 13485:2016, our ELIQUENT experts have done the work to identify all the details you need to know about the shift from the QSR to the QMSR and ISO 13485:2016. We offer two different instructor-led training courses focused on the QMSR to meet your needs. The first is a one-day high-level course on QMSR, which you can find <a href=\"https:\/\/www.orielstat.com\/coursedetailnew.aspx?mpgid=16&amp;pgid=16&amp;cpaid=3&amp;cspaid=4&amp;courseid=302\">here<\/a>. The second is an in-depth course on both QMSR and ISO13485:2016, which you can find <a href=\"https:\/\/www.orielstat.com\/coursedetailnew.aspx?mpgid=16&amp;pgid=16&amp;cpaid=3&amp;cspaid=4&amp;courseid=307\">here<\/a>. Both of these courses include the information that you need to jumpstart your transition to the QMSR.<\/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-5e065f4 elementor-widget elementor-widget-text-editor\" data-id=\"5e065f4\" 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 also can help you evaluate your initial readiness for next February when QMSR goes into effect by assisting with a gap analysis (<a href=\"https:\/\/www.orielstat.com\/practice\/internal-and-supplier-audits-for-ISO-13485-and-FDAs-QSR-consulting\" target=\"_blank\" rel=\"nofollow noopener\">have us do it for you<\/a>) to get a much clearer understanding of what needs to happen to get your QMS in conformance with the new QMSR.\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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href=\"#mailmunch-pop-545876\"><img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/Blog-subscribe.jpg\" alt=\"\"><\/a><\/figure><\/section><section id=\"categories-3\" class=\"widget widget_categories\"><h2 class=\"widget-title\">Search by Topic<\/h2>\n\t\t\t<ul>\n\t\t\t\t\t<li class=\"cat-item cat-item-12\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/all-medical-device-ra-qa\/\">All Category<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-74\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/ai\/\">Artificial Intelligence (AI)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-64\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/auditing\/\">Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-71\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa\/\">CAPA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-20\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root 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>Less Than A Year! FDA&#8217;s QMSR Is Getting Closer The new Quality Management System Regulation (QMSR) \u2013 FDA\u2019s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 \u2013 is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4739,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,4,72],"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\/less-than-a-year-qmsr-is-getting-closer\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Less Than A Year! FDA&#8217;s QMSR Is Getting Closer The new Quality Management System Regulation (QMSR) \u2013 FDA\u2019s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 \u2013 is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/less-than-a-year-qmsr-is-getting-closer\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2025-03-31T22:07:38+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2025-03-31T22:14:29+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/06\/FDA-MEDICALDEVICES.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1773\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1182\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"Oriel STAT A MATRIX\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Oriel STAT A MATRIX\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/less-than-a-year-qmsr-is-getting-closer\/","og_locale":"en_US","og_type":"article","og_description":"Less Than A Year! FDA&#8217;s QMSR Is Getting Closer The new Quality Management System Regulation (QMSR) \u2013 FDA\u2019s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 \u2013 is just one year away from becoming effective. 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