{"id":1754,"date":"2017-05-30T16:27:18","date_gmt":"2017-05-30T19:27:18","guid":{"rendered":"http:\/\/passarini.com.br\/blog\/"},"modified":"2026-06-16T17:15:34","modified_gmt":"2026-06-16T20:15:34","slug":"blog","status":"publish","type":"page","link":"https:\/\/passarini.com.br\/en\/blog\/","title":{"rendered":"Blog"},"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:center top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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-bottom:0px;--awb-flex-wrap:wrap;\" id=\"quem-somos-banner-container\" ><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-bg-size:cover;\"><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%;\" id=\"quem-somos-slider\"><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\/2021\/09\/1920x500_banner_blog.webp\" alt=\"blog banner\" width=\"1920\" height=\"500\" class=\"wp-image-7194\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog.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-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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:40px;--awb-padding-bottom:100px;--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_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last fusion-column-no-min-height\" style=\"--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h1 style=\"text-align: center;\">Passarini Blog<\/h1>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-infinite\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:15px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -15px !important; margin-right:-15px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-infinite fusion-posts-container-load-more fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope fusion-blog-equal-heights\" data-pages=\"14\" data-grid-col-space=\"30\" style=\"margin: -15px -15px 0;min-height:500px;\"><article id=\"blog-1-post-13252\" class=\"fusion-post-grid post-13252 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/fda-regulatory-updates-2026-medical-devices\/\" aria-label=\"FDA Regulatory Updates 2026: The Comprehensive Medical Device Guide\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"FDA 2026: The Complete Guide to New Medical Device Regulatory Requirements in the US\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/09\/feed-noticia-passarini-azul-FDA-2026-EN.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/fda-regulatory-updates-2026-medical-devices\/\">FDA Regulatory Updates 2026: The Comprehensive Medical Device Guide<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     FDA 2026: The Complete Guide to New Medical Device Regulatory Requirements in the US If you work in the medical device industry and believe your FDA clearance process is under control for 2026, it is time to raise the alarm. The recent US regulatory updates [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13240\" class=\"fusion-post-grid post-13240 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/clarkemodet-acquires-passarini-group-regulatory-affairs\/\" aria-label=\"ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod.png\" class=\"attachment-full size-full wp-post-image\" alt=\"ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-200x250.png 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-400x500.png 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-600x750.png 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod-800x1000.png 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/08\/feed-BLOG-Passarini-EN-ClarkeMod.png 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/clarkemodet-acquires-passarini-group-regulatory-affairs\/\">ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     ClarkeModet acquires Passarini Group to strengthen its global Regulatory Affairs offering The acquisition expands ClarkeModet's regulatory capabilities and reinforces its position as a strategic partner for healthcare and life sciences organizations. Madrid \/ Rio de Janeiro \/ S\u00e3o Paulo, September 1, 2026 \u2013 ClarkeModet has [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13193\" class=\"fusion-post-grid post-13193 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/eudamed-mandatory-medical-device-compliance-eu\/\" aria-label=\"EUDAMED Enforcement: Essential Requirements for Medical Device Operators\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"Eudamed\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/eudamed-mandatory-medical-device-compliance-eu\/\">EUDAMED Enforcement: Essential Requirements for Medical Device Operators<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers? Published by Passarini Group | Regulatory Affairs &amp; International Market As of May 28, 2026, the European medical device sector has undergone a significant structural transformation: four modules of EUDAMED\u2014the European Database on [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13115\" class=\"fusion-post-grid post-13115 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\" aria-label=\"SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\">SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines The medical device sector in Brazil has just taken a historic step towards total traceability. During the 2nd Ordinary Public Meeting of the Collegiate Board (DICOL) in 2026, Anvisa approved the Normative [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13090\" class=\"fusion-post-grid post-13090 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en category-regulatory tag-anvisa-en tag-anvisa-notification tag-anvisa-registration tag-anvisa-regulation tag-anvisa-rejection tag-brazilian-market tag-class-i-products tag-class-ii-products tag-medical-devices tag-passarini-group tag-public-health tag-rdc-751-2022 tag-regulatory-compliance tag-regulatory-consulting\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\" aria-label=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\" 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=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\">FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices The 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 [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13024\" class=\"fusion-post-grid post-13024 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en category-regulatory tag-anvisa-en tag-anvisa-notification tag-anvisa-registration tag-anvisa-regulation tag-anvisa-rejection tag-brazilian-market tag-class-i-products tag-class-ii-products tag-medical-devices tag-passarini-group tag-public-health tag-rdc-751-2022 tag-regulatory-compliance tag-regulatory-consulting\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\" aria-label=\"The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"The Simplified Process Trap: Why Do Class I and II Products Lead ANVISA Denials?\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-66x66.webp 66w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-150x150.webp 150w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-200x200.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-300x300.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-400x400.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-600x600.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-768x768.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-800x800.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-1024x1024.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\">The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     The Myth of the \"Easy\" Process In the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that \"it seems easy, but it's not!\". 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