{"id":13090,"date":"2026-02-02T15:14:19","date_gmt":"2026-02-02T18:14:19","guid":{"rendered":"https:\/\/passarini.com.br\/simplified-process-trap-anvisa-denials-class-i-ii-2\/"},"modified":"2026-02-02T16:07:37","modified_gmt":"2026-02-02T19:07:37","slug":"fda-qmsr-medical-device-regulation-update","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/","title":{"rendered":"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2><b>FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices<\/b><\/h2>\n<p>The U.S. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\">Food and Drug Administration<\/a> (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR Part 820. This new regulation will come into effect on February 2, 2026, and represents one of the biggest regulatory advancements in medical device quality management in recent decades.<\/p>\n<p>The QMSR incorporates by reference the international standard ISO 13485:2016 \u2013 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes, as well as selected clauses from ISO 9000:2015 \u2013 Quality management systems \u2013 Fundamentals and vocabulary. This incorporation approach enhances harmonization between the U.S. regulatory system and international standards, promoting greater consistency, reducing regulatory barriers, and aligning with globally recognized quality management practices.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p>Among the main changes, a more explicit integration of risk management concepts throughout the entire product lifecycle stands out \u2013 something that was less detailed in the old QSR \u2013 and which is now a central requirement under the QMSR framework. This means that manufacturers will need to demonstrate that risk processes, monitoring, continuous improvement, and compliance are effectively integrated into the quality management system.<\/p>\n<p>For international and national manufacturers wishing to commercialize medical devices in the U.S., the new QMSR reinforces the need for compliance reviews, gap analyses, and eventual updating of procedures, data, and technical documentation based on the requirements of ISO 13485:2016.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"400\" height=\"500\" alt=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\" title=\"feed-noticia-passarini-preto_EN_FDA\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-400x500.webp\" class=\"img-responsive wp-image-13098\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<p>Furthermore, the FDA has ceased using the old &#8220;Quality System Inspection Technique (QSIT)&#8221; and adopted a new inspection model aligned with QMSR, reflecting the agency&#8217;s commitment to modern oversight and quality assurance practices.<\/p>\n<p>Passarini Group is prepared to support medical device companies in this regulatory transition, offering compliance analysis services, adaptation of quality management systems, and personalized technical-regulatory support to meet the new FDA requirements.<\/p>\n<p>Contact us to learn more about our services and how we can facilitate your sales in Brazil. Reach out to us at <a href=\"mailto:contato@passarini.com.br\"><b data-path-to-node=\"4,0\" data-index-in-node=\"112\">contato@passarini.com.br<\/b><\/a><\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\" data-description=\"FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices\r\nThe U.S. Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR Part 820. This new regulation will\" data-link=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\"><h4 class=\"tagline\" style=\"color:#333333;\">Share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Ffda-qmsr-medical-device-regulation-update&amp;t=FDA%20Unleashes%20New%20QMSR%3A%20A%20Game%20Changer%20for%20Medical%20Device%20Quality%20Management\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a 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