{"id":7798,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/nossas-solucoes-europa\/"},"modified":"2026-02-11T08:55:22","modified_gmt":"2026-02-11T11:55:22","slug":"suporte-registro-mdr","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/","title":{"rendered":"Nossas solu\u00e7\u00f5es Europa"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7798\" class=\"elementor elementor-7798 elementor-1469\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad1e1b9 e-flex e-con-boxed e-con e-parent\" data-id=\"ad1e1b9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-412d638 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"412d638\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Suporte regulat\u00f3rio: registro MDR \u200b<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-95193cf elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"95193cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"To access the European market, manufacturers must demonstrate full conformity with MDR 2017\/745 and obtain CE Marking. Sobel provides tailored support for medical device Europe compliance, helping you prepare documentation, conduct evaluations, and work effectively with Notified Bodies.\"}]\" data-inline-monday=\"true\">Para acessar o mercado europeu, os fabricantes precisam demonstrar conformidade com o MDR 2017\/745 e obter o CE Mark. A Sobel oferece suporte personalizado ao longo do registro MDR, auxiliando na prepara\u00e7\u00e3o da documenta\u00e7\u00e3o t\u00e9cnica, na condu\u00e7\u00e3o das avalia\u00e7\u00f5es aplic\u00e1veis e na intera\u00e7\u00e3o com os organismos notificados. <\/p>\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-84105ca elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"84105ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#footer-cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Receba suporte<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5ad3781 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"5ad3781\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23dc695 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"23dc695\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4edf4a6 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4edf4a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quem se beneficia dos nossos servi\u00e7os de registro MDR\u200b<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fee426a e-flex e-con-boxed e-con e-parent\" data-id=\"fee426a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-60578af e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"60578af\" data-element_type=\"container\" data-e-type=\"container\" 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elementor-widget-text-editor\" data-id=\"ed0892c\" data-element_type=\"widget\" data-e-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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"requiring expert guidance to align with MDR 2017\/745 and achieve CE Marking certification.\"}]\" data-inline-monday=\"true\">que precisam de orienta\u00e7\u00e3o especializada para alinhamento com a MDR 2017\/745 e obten\u00e7\u00e3o da marca\u00e7\u00e3o CE.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28c6bcf e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"28c6bcf\" data-element_type=\"container\" data-e-type=\"container\" 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e-con-full e-flex e-con e-child\" data-id=\"6574876\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2a489 elementor-widget elementor-widget-heading\" data-id=\"fb2a489\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Empresas internacionais<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c272d8 elementor-widget elementor-widget-text-editor\" data-id=\"5c272d8\" data-element_type=\"widget\" data-e-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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"looking to expand into Europe with support in regulatory submissions, documentation, and Authorized Representative services.\"}]\" data-inline-monday=\"true\">buscando expandir-se para a Europa, com apoio em submiss\u00f5es regulat\u00f3rias, documenta\u00e7\u00e3o e servi\u00e7os de Representante Autorizado.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-73d80d9 e-flex e-con-boxed e-con e-parent\" data-id=\"73d80d9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c4d3a2a e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"c4d3a2a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-0256f96 e-con-full e-flex e-con e-child\" 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186.95H292.22C296.64 186.95 300.21 190.53 300.21 194.94C300.21 199.35 296.63 202.93 292.22 202.93H178.25C173.83 202.94 170.25 199.36 170.25 194.94ZM170.25 234C170.25 229.58 173.83 226.01 178.24 226.01H277.79C282.21 226.01 285.78 229.59 285.78 234C285.78 238.41 282.2 241.99 277.79 241.99H178.24C173.83 242 170.25 238.42 170.25 234ZM170.25 273.04C170.25 268.62 173.83 265.05 178.24 265.05H293.78C298.2 265.05 301.77 268.63 301.77 273.04C301.77 277.45 298.19 281.03 293.78 281.03H178.25C173.83 281.03 170.25 277.45 170.25 273.04Z\" fill=\"white\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e5feb89 e-con-full e-flex e-con e-child\" data-id=\"e5feb89\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29bfb1f elementor-widget elementor-widget-heading\" data-id=\"29bfb1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Equipes de assuntos regulat\u00f3rios<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b8d9bc elementor-widget elementor-widget-text-editor\" data-id=\"2b8d9bc\" data-element_type=\"widget\" data-e-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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"needing assistance with technical files, clinical evaluation reports (CER), and ongoing MDR updates.\"}]\" data-inline-monday=\"true\">com a necessidade de assist\u00eancia com documentos t\u00e9cnicos, relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica (CER) e atualiza\u00e7\u00f5es cont\u00ednuas de MDR.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fe23d0c animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"fe23d0c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cd2b350 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd2b350\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1182404 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"1182404\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Suporte de ponta a ponta<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f02b925 elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"f02b925\" data-element_type=\"widget\" data-e-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\t\t<p>A entrada de um dispositivo m\u00e9dico no mercado europeu exige a conformidade com os procedimentos do MDR 2017\/745 e da marca\u00e7\u00e3o CE. Muitos fabricantes enfrentam d\u00favidas recorrentes ao preparar a documenta\u00e7\u00e3o, trabalhar com os organismos notificados e gerenciar as responsabilidades p\u00f3s-mercado. <\/p><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Here are some of the most common questions:\"}]\" data-inline-monday=\"true\"><strong>Aqui est\u00e3o algumas das perguntas mais comuns:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-092dc2c e-flex e-con-boxed e-con e-parent\" data-id=\"092dc2c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5644378 elementor-widget elementor-widget-spacer\" data-id=\"5644378\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5efb7e0 elementor-widget-mobile__width-initial elementor-absolute elementor-widget elementor-widget-image\" data-id=\"5efb7e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_direction&quot;:&quot;negative&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:50}},&quot;motion_fx_translateX_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateX_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:50}},&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:51}},&quot;motion_fx_rotateZ_effect&quot;:&quot;yes&quot;,&quot;motion_fx_rotateZ_direction&quot;:&quot;negative&quot;,&quot;motion_fx_rotateZ_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4.7,&quot;sizes&quot;:[]},&quot;motion_fx_rotateZ_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:52}},&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_translateX_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"417\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-3-417x1024.png\" class=\"attachment-large size-large wp-image-24129\" alt=\"Illustration of a medicine bottle.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-3-417x1024.png 417w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-3-122x300.png 122w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-3-625x1536.png 625w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-3.png 700w\" sizes=\"(max-width: 417px) 100vw, 417px\" \/>\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-557992b elementor-widget-mobile__width-initial elementor-absolute elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"557992b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:51}},&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:51}},&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"700\" height=\"564\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-2.png\" class=\"attachment-large size-large wp-image-24123\" alt=\"Illustration of a hospital heart monitor.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-2.png 700w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-2-300x242.png 300w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/>\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-cddffb8 elementor-widget-mobile__width-initial elementor-absolute elementor-widget elementor-widget-image\" data-id=\"cddffb8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:56}},&quot;motion_fx_translateX_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateX_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:50}},&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:36}},&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_translateX_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"700\" height=\"383\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-1.png\" class=\"attachment-large size-large wp-image-24117\" alt=\"Illustration of common objects in a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-1.png 700w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vector-1-300x164.png 300w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/>\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-ad22026 elementor-widget-mobile__width-initial elementor-absolute elementor-widget elementor-widget-image\" data-id=\"ad22026\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_direction&quot;:&quot;negative&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:63}},&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:51}},&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"449\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/element1.png\" class=\"attachment-large size-large wp-image-13374\" alt=\"Organic shape.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/element1.png 449w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/08\/element1-300x194.png 300w\" sizes=\"(max-width: 449px) 100vw, 449px\" \/>\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-32b550a elementor-invisible elementor-widget elementor-widget-n-accordion\" data-id=\"32b550a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-5310\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-5310\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> O que \u00e9 o MDR 2017\/745 e por que ele \u00e9 importante? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-5310\" class=\"elementor-element elementor-element-13bc0b1 e-con-full e-flex e-con e-child\" data-id=\"13bc0b1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1c4b4a7 elementor-widget elementor-widget-text-editor\" data-id=\"1c4b4a7\" data-element_type=\"widget\" data-e-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\t\t<p>O Regulamento de Dispositivos M\u00e9dicos (MDR 2017\/745) \u00e9 a estrutura jur\u00eddica que rege todos os dispositivos m\u00e9dicos na Europa. Ele define regras de classifica\u00e7\u00e3o, avalia\u00e7\u00f5es de conformidade e obriga\u00e7\u00f5es p\u00f3s-mercado. A conformidade com o MDR \u00e9 obrigat\u00f3ria para qualquer dispositivo comercializado no mercado europeu.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-806a1f1 elementor-invisible elementor-widget elementor-widget-n-accordion\" data-id=\"806a1f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:500,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1340\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1340\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> O que \u00e9 necess\u00e1rio para obter o CE Mark para dispositivos m\u00e9dicos? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1340\" class=\"elementor-element elementor-element-01dd953 e-con-full e-flex e-con e-child\" data-id=\"01dd953\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b052d06 elementor-widget elementor-widget-text-editor\" data-id=\"b052d06\" data-element_type=\"widget\" data-e-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\t\t<p>A marca\u00e7\u00e3o CE mostra que um dispositivo atende aos padr\u00f5es de seguran\u00e7a e desempenho europeus. Para obter a certifica\u00e7\u00e3o, os fabricantes devem preparar documenta\u00e7\u00e3o t\u00e9cnica, realizar avalia\u00e7\u00f5es cl\u00ednicas e de risco e concluir a avalia\u00e7\u00e3o de conformidade apropriada. A Sobel d\u00e1 suporte \u00e0s empresas durante todo esse processo, para alcan\u00e7ar o alinhamento com as expectativas da Uni\u00e3o Europeia.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-626a3fa elementor-invisible elementor-widget elementor-widget-n-accordion\" data-id=\"626a3fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:900,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1030\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1030\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Os fabricantes precisam de um representante autorizado na Uni\u00e3o Europeia? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1030\" class=\"elementor-element elementor-element-1767498 e-con-full e-flex e-con e-child\" data-id=\"1767498\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d4eae34 elementor-widget elementor-widget-text-editor\" data-id=\"d4eae34\" data-element_type=\"widget\" data-e-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\t\t<p>Sim, empresas sem presen\u00e7a f\u00edsica na Uni\u00e3o Europeia devem nomear um Representante Autorizado. Essa entidade \u00e9 legalmente respons\u00e1vel pela comunica\u00e7\u00e3o com os \u00f3rg\u00e3os reguladores e por manter a documenta\u00e7\u00e3o, como o arquivo t\u00e9cnico. A Sobel oferece servi\u00e7os de European Authorized Representative para fabricantes estrangeiros.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ccbf95 elementor-invisible elementor-widget elementor-widget-n-accordion\" data-id=\"6ccbf95\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:1300,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1140\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1140\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Quais s\u00e3o as obriga\u00e7\u00f5es de vigil\u00e2ncia p\u00f3s-mercado de acordo com o MDR? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"lnr lnr-chevron-down-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1140\" class=\"elementor-element elementor-element-380a610 e-con-full e-flex e-con e-child\" data-id=\"380a610\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e5a2e76 elementor-widget elementor-widget-text-editor\" data-id=\"e5a2e76\" data-element_type=\"widget\" data-e-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\t\t<p>Os fabricantes devem monitorar continuamente a seguran\u00e7a e o desempenho de seus dispositivos quando estiverem no mercado. Isso inclui relat\u00f3rios de vigil\u00e2ncia, atualiza\u00e7\u00f5es peri\u00f3dicas de seguran\u00e7a e a\u00e7\u00f5es corretivas, se necess\u00e1rio. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef7fe7b e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"ef7fe7b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-92db1c1 elementor-widget elementor-widget-text-editor\" data-id=\"92db1c1\" data-element_type=\"widget\" data-e-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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Sobel helps you manage every step of MDR compliance, giving your company clarity, efficiency, and confidence to grow in Europe.\"}]\" data-inline-monday=\"true\">A Sobel ajuda voc\u00ea a gerenciar cada etapa da conformidade, da prepara\u00e7\u00e3o de documentos ao registro MDR\u200b, proporcionando \u00e0 sua empresa clareza, efici\u00eancia e confian\u00e7a para crescer na Europa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37802bb e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"37802bb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3163c0f e-con-full e-flex e-con e-child\" data-id=\"3163c0f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-624190c elementor-widget elementor-widget-heading\" data-id=\"624190c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Como a Sobel apoia a conformidade de dispositivos m\u00e9dicos na Europa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1df8bc9 elementor-widget elementor-widget-heading\" data-id=\"1df8bc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Para atender aos requisitos do MDR 2017\/745 e obter o CE Mark, sua empresa precisa de documenta\u00e7\u00e3o estruturada, avalia\u00e7\u00f5es bem desenvolvidas e alinhamento constante com as atualiza\u00e7\u00f5es regulamentares. Sem o conhecimento adequado, essas etapas podem atrasar a sua entrada no mercado. <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f591a0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7f591a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16cacce elementor-widget elementor-widget-text-editor\" data-id=\"16cacce\" data-element_type=\"widget\" data-e-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\t\t<p><strong>A Sobel oferece suporte pr\u00e1tico e estrat\u00e9gico em todas as etapas.<\/strong> Nossos consultores auxiliam na compila\u00e7\u00e3o e revis\u00e3o de arquivos t\u00e9cnicos, na prepara\u00e7\u00e3o de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica (CER), na coordena\u00e7\u00e3o de avalia\u00e7\u00f5es biol\u00f3gicas (BER) e toxicol\u00f3gicas (TRA), e na implementa\u00e7\u00e3o do gerenciamento de riscos de acordo com a norma ISO 14971.<\/p><p>Para empresas de fora da Uni\u00e3o Europeia, a Sobel atua como seu representante autorizado e oferece servi\u00e7os de PRRC (Person Responsible for Regulatory Compliance, pessoa respons\u00e1vel pela conformidade regulamentar), fazendo com que suas obriga\u00e7\u00f5es sejam cobertas por um parceiro local confi\u00e1vel.<\/p><p>Ao trabalhar com a Sobel, sua empresa ganha agilidade, confian\u00e7a regulat\u00f3ria e um posicionamento mais forte para competir com sucesso no mercado europeu de dispositivos m\u00e9dicos.<\/p>\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-45a8a05 elementor-widget elementor-widget-button\" data-id=\"45a8a05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#our-services\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Comece agora!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-60cd8c6 e-con-full e-flex e-con e-child\" data-id=\"60cd8c6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9c3fe17 elementor-widget elementor-widget-image\" data-id=\"9c3fe17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"2000\" height=\"1333\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec.jpg\" class=\"attachment-full size-full wp-image-15528\" alt=\"The image shows a modern workspace, likely in a laboratory or engineering environment. In the foreground, there is a blue hard plastic case with safety goggles resting on top. A blue lanyard with an ID badge is placed next to it. In the background, two computer monitors display 3D models or technical drawings of robotic arms. The workspace also includes a keyboard, mouse, and a cup holding colored pens, all set on a clean white desk. The scene conveys a professional and organized environment focused on design, testing, or manufacturing technology.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec.jpg 2000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-1024x682.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-768x512.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-1536x1024.jpg 1536w\" sizes=\"(max-width: 2000px) 100vw, 2000px\" \/>\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-7be2ab0 elementor-widget elementor-widget-menu-anchor\" data-id=\"7be2ab0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"nossosservios\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6d0e0a4 e-flex e-con-boxed e-con e-parent\" data-id=\"6d0e0a4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-761d811 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"761d811\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conformidade regulat\u00f3ria para dispositivos m\u00e9dicos com a Sobel<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8852f72 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8852f72\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:300}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"You can count on Sobel to provide comprehensive support for medical device Europe compliance, covering the full pathway to CE Marking and MDR 2017\/745 obligations.\"}]\" data-inline-monday=\"true\">Voc\u00ea pode contar com a Sobel para ter suporte abrangente para a conformidade de dispositivos m\u00e9dicos na Europa, cobrindo todo o caminho para a marca\u00e7\u00e3o CE e registro MDR\u200b 2017\/745.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9f46710 e-con-full e-flex elementor-invisible e-con e-parent\" data-id=\"9f46710\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInLeft&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f948cfe elementor-widget elementor-widget-ucaddon_cover_flow_carousel\" data-id=\"f948cfe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_cover_flow_carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Coverflow Carousel -->\n\t\t<link id='uc_ac_assets_file_jquery_flipster_css_16350-css' href='https:\/\/sobelconsult.com\/wp-content\/uploads\/ac_assets\/cover_flow_carousel\/jquery.flipster.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Coverflow Carousel *\/\n\n#uc_cover_flow_carousel_elementor_f948cfe{\n  display: none;\n  min-height: 1px;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__item img{  \n  display:block;\n  width:100%;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__item__content{\n  overflow:hidden;\n  position:relative;  \n  }\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__nav__item a{\n  z-index:1;\n}\n\n.ue-flip-item-title{\n  font-size:21px;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .ue-item-btn a{\n  text-decoration:none;\n  text-align:center;\n  transition:0.3s;\n}\n\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__button{\n  line-height:1em;\n  margin:0;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .ue-flip-item-icon{\n  line-height:1em;\n  display:inline-flex;\n  justify-content:center;\n  align-items:center;  \n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .ue-flip-item-icon svg{\n  height:1em;\n  width:1em;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__container, \n#uc_cover_flow_carousel_elementor_f948cfe .flipster__item, \n#uc_cover_flow_carousel_elementor_f948cfe .flipster__item__content{\n  transition:500ms;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__nav__link::after{\n  background-color:#141414;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__nav__item a{\n  color:#141414;\n}\n\n#uc_cover_flow_carousel_elementor_f948cfe .flipster__nav__item--current>.flipster__nav__link{\n  color:#ffffff;\n}\n\n<\/style>\n\n<div class=\"ue-coverflow  uc-remote-parent  \" id=\"uc_cover_flow_carousel_elementor_f948cfe\"  data-remoteid='auto' data-widgetname='Coverflow Carousel' data-sync='true' data-syncid='group1' >\n  <ul class=\"flip-items uc-items-wrapper\">\n    <li class=\"ue-coverflow-item\" data-flip-title=\"Suporte regulat\u00f3rio para CE Mark\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-acebc4a-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Suporte regulat\u00f3rio para CE Mark<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Gap analysis, technical documentation, and ongoing regulatory \"},{\"attributes\":{\"sanitizedSize\":\"16px\"},\"insert\":\"for CE Mark for Medical Devices\"},{\"insert\":\".\"}]\" data-inline-monday=\"true\">An\u00e1lise de lacunas, documenta\u00e7\u00e3o t\u00e9cnica e suporte para CE Mark.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/ce-mark-para-dispositivos-medicos\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Avalia\u00e7\u00e3o Biol\u00f3gica (BEP, BER)\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-4fbb103-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Avalia\u00e7\u00e3o Biol\u00f3gica (BEP, BER)<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Expert biological evaluation services. BEP, BER, Gap analysis, and regulatory support.\"}]\" data-inline-monday=\"true\">Servi\u00e7os de avalia\u00e7\u00e3o biol\u00f3gica. BEP, BER, an\u00e1lise de lacunas e suporte regulat\u00f3rio. <\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/avaliacao-biologica-na-europa\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Avalia\u00e7\u00e3o cl\u00ednica (CEP e CER)\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-902792c-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Avalia\u00e7\u00e3o cl\u00ednica (CEP e CER)<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Structured clinical evaluation. CEP, CER, literature search, and Notified Body support.\"}]\" data-inline-monday=\"true\">Avalia\u00e7\u00e3o cl\u00ednica estruturada. CEP, CER, pesquisa de literatura e suporte a \u00f3rg\u00e3os notificados. <\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/avaliacao-clinica-na-europa\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Avalia\u00e7\u00e3o de risco toxicol\u00f3gico (TRA)\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-c63f87c-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Avalia\u00e7\u00e3o de risco toxicol\u00f3gico (TRA)<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"TRA aligned with EU MDR and ISO 10993 series, supporting chemical safety evidence.\"}]\" data-inline-monday=\"true\">Evid\u00eancias de seguran\u00e7a qu\u00edmica com TRA alinhado ao MDR da UE e ISO 10993.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/avaliacao-de-risco-toxicologico-para-europa\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Representante autorizado europeu\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-3be9cd7-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Representante autorizado europeu<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"EAR for medical devices, supporting regulatory oversight and access to the EU market.\"}]\" data-inline-monday=\"true\">EAR para dispositivos m\u00e9dicos, apoiando o acesso ao mercado da UE.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/representante-europeu-autorizado-para-mdr\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Gerenciamento de qualidade\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-b9909a3-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Gerenciamento de qualidade<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Quality management support, aligned with EU MDR and ISO 13485 requirements.\"}]\" data-inline-monday=\"true\">Suporte ao SGQ, alinhado aos requisitos do EU MDR e da ISO 13485.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/sistema-da-qualidade-mdr-europa\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Auditorias internas\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-b47472c-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Auditorias internas<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.\"}]\" data-inline-monday=\"true\">Auditorias internas para conformidade com ISO 13485 e com os \u00f3rg\u00e3os notificados.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/medical-device-internal-audits\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Qualifica\u00e7\u00e3o e auditoria de fornecedores\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-b26ee80-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Qualifica\u00e7\u00e3o e auditoria de fornecedores<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Audits and qualification aligned with ISO 13485 and EU MDR for medical devices.\"}]\" data-inline-monday=\"true\">Auditorias e qualifica\u00e7\u00e3o alinhadas com a ISO 13485 e a EU MDR.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/auditoria-e-qualificacao-de-fornecedores-na-europa\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n<li class=\"ue-coverflow-item\" data-flip-title=\"Treinamento em Assuntos Regulat\u00f3rios\">\n\n  \n    \n      <div class=\"ue-flip-item-content elementor-repeater-item-e58a3c1-item-content\">\n      <div class=\"ue-flip-item-content-inside\">\n                <div class=\"ue-flip-item-title\">Treinamento em Assuntos Regulat\u00f3rios<\/div>        <div class=\"ue-flip-item-text\"><div class=\"elementor-element elementor-element-798fa52 elementor-widget elementor-widget-text-editor\" data-id=\"798fa52\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Expert-led courses on CE Marking, EU MDR, UK MDR, and more.\"}]\" data-inline-monday=\"true\">Cursos sobre marca\u00e7\u00e3o CE, MDR da UE, MDR do Reino Unido e muito mais.<\/p>\n<\/div>\n<\/div>\n<\/div>               \t  <div class=\"ue-item-btn\">\n                          <a href=\"https:\/\/sobelconsult.com\/pt-br\/suporte-registro-mdr\/treinamento-mdr-medical-device-regulations\/\"  target='_blank' class=\"\">Saiba mais<\/a>\n       \t     \n          <\/div>\n                <div class=\"ue-item-template\"><\/div>\n      <\/div>\n    <\/div>\n  <\/li>\n\n  <\/ul>\n<\/div>\n<!-- end Coverflow Carousel -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-86de879 e-flex e-con-boxed e-con e-parent\" data-id=\"86de879\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-937b2b4 elementor-widget elementor-widget-image\" data-id=\"937b2b4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1240\" height=\"827\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vetor-md-optimized.png\" class=\"attachment-full size-full wp-image-24135\" alt=\"Illustration of two people doing business. They shake hands and there is a drawing of a document. On the sides, on one side, an illustration of a man holding a bag and, on the other, a man sitting writing on a laptop.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vetor-md-optimized.png 1240w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vetor-md-optimized-300x200.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vetor-md-optimized-1024x683.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/vetor-md-optimized-768x512.png 768w\" sizes=\"(max-width: 1240px) 100vw, 1240px\" \/>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fe8aa24 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"fe8aa24\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4401e44 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4401e44\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-83813fb elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"83813fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Da conformidade \u00e0 confian\u00e7a<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35633de elementor-widget elementor-widget-text-editor\" data-id=\"35633de\" data-element_type=\"widget\" data-e-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\t\t<p>A expans\u00e3o no mercado europeu de dispositivos m\u00e9dicos exige mais do que conhecimento t\u00e9cnico: exige um parceiro regulat\u00f3rio confi\u00e1vel. A Sobel simplifica o processo de registro MDR\u200b, ajudando sua empresa a transformar a conformidade em uma vantagem competitiva. <\/p><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"By partnering with us, you gain:\"}]\" data-inline-monday=\"true\"><strong>Ao se tornar parceiro Sobel, voc\u00ea ganha:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-43d5a3e e-con-full e-flex e-con e-child\" data-id=\"43d5a3e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f239ff0 elementor-widget__width-initial elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-invisible elementor-widget elementor-widget-icon-box\" data-id=\"f239ff0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tOrienta\u00e7\u00e3o especializada sobre MDR 2017\/745 e procedimentos de CE Mark.\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b51d13 elementor-widget__width-initial elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-invisible elementor-widget elementor-widget-icon-box\" data-id=\"2b51d13\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tRedu\u00e7\u00e3o do risco de atrasos, rejei\u00e7\u00f5es ou retrabalho.\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71b9175 elementor-widget__width-initial elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-invisible elementor-widget elementor-widget-icon-box\" data-id=\"71b9175\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tSuporte com documenta\u00e7\u00e3o t\u00e9cnica, CER, BER e requisitos p\u00f3s-mercado.\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5611ca1 elementor-widget__width-initial elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-invisible elementor-widget elementor-widget-icon-box\" data-id=\"5611ca1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tPresen\u00e7a local por meio de servi\u00e7os de Representante Autorizado e PRRC.\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d54951c e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"d54951c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bfb374b elementor-widget elementor-widget-heading\" data-id=\"bfb374b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Simplifica\u00e7\u00e3o da conformidade no registro MDR\u200b da Uni\u00e3o Europeia<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-387e52a elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"387e52a\" data-element_type=\"widget\" data-e-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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From documentation to Authorized Representation, Sobel supports every step of your medical device journey in Europe.\"}]\" data-inline-monday=\"true\">Desde a documenta\u00e7\u00e3o at\u00e9 a Representa\u00e7\u00e3o Autorizada, a Sobel d\u00e1 suporte a todas as etapas da jornada de seu dispositivo m\u00e9dico na Europa.<\/p>\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-cf08f29 elementor-widget elementor-widget-button\" data-id=\"cf08f29\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Obtenha suporte!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-22f98f3 e-flex e-con-boxed e-con e-parent\" data-id=\"22f98f3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b96bc9d e-con-full e-flex e-con e-child\" data-id=\"b96bc9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-231e3d7 elementor-widget elementor-widget-heading\" data-id=\"231e3d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Artigos mais recentes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ea3dd elementor-widget elementor-widget-heading\" data-id=\"75ea3dd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Descubra tend\u00eancias, dicas e insights de especialistas para se manter atualizado<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-582bac1 elementor-widget elementor-widget-ucaddon_post_list\" data-id=\"582bac1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_post_list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Post List -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Post List *\/\n\n\r\n@keyframes uc_post_list_elementor_582bac1__item-animation {\r\n  0% {\r\n            \r\n        \t        \tfilter: blur(10px);\r\n\t\t\t\r\n    \t    opacity: 0;\r\n  }\r\n  100% {\r\n            \r\n        \t            filter: blur(0px);\r\n            \r\n    \t\topacity: 1;\r\n  }\r\n}\r\n\r\n\r\n#uc_post_list_elementor_582bac1 .uc_post_list_box{\r\n\topacity:0;\r\n}\r\n\r\n\r\n#uc_post_list_elementor_582bac1 .uc-entrance-animate {\r\n  opacity:1;\r\n}\r\n\r\n#uc_post_list_elementor_582bac1 .uc-entrance-animate 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flex:1;\n}\n\n#uc_post_list_elementor_582bac1 .uc_more_btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n  position: relative;\n  z-index: 1;\n}\n\n#uc_post_list_elementor_582bac1 .button-on-side{\n  display:flex;\n  align-items:center;\n}\n\n#uc_post_list_elementor_582bac1 .ue-grid-item-category{\n  display: flex;\n  align-items: center;\n}\n\n.ue-grid-item-category a{\n  display:inline-block;\n  font-size:10px;\n  text-transform:uppercase;\n  white-space: nowrap;\n}\n\n#uc_post_list_elementor_582bac1 .ue-meta-data{  \n  display:flex;\n  flex-wrap: wrap;\n  line-height:1em;\n}\n\n#uc_post_list_elementor_582bac1 .ue-grid-item-meta-data{\n      display:inline-flex;\n      align-items:center;\n}\n\n.ue-grid-item-meta-data{\n  font-size:12px;\n}\n\n#uc_post_list_elementor_582bac1 .ue-grid-item-meta-data-icon{\n  line-height:1em;\n}\n\n#uc_post_list_elementor_582bac1 .ue-grid-item-meta-data-icon svg{\n  width:1em;\n  height:1em;\n} \n\n#uc_post_list_elementor_582bac1 .ue-debug-meta{\n  padding:10px;\n  border:1px solid red;\n  position:relative;\n  line-height:1.5em;\n  font-size:11px;\n  width:100%;\n}\n\n.uc-remote-parent .uc_post_list_box{\n\tcursor:pointer;\n}\n\n#uc_post_list_elementor_582bac1 .ue-post-link-overlay{\n  display:block;\n  position:absolute;\n  top:0;\n  bottom:0;\n  right:0;\n  left:0;\n}\n\n\n\n\n<\/style>\n\n<div class=\"uc_post_list uc-items-wrapper \" id=\"uc_post_list_elementor_582bac1\"  >    \t\n  <div class=\"uc_post_list_box\" data-category=\"Not\u00edcias\">\n  \n  \t    <div class=\"uc_post_list_image\">\n      <a href=\"https:\/\/sobelconsult.com\/pt-br\/news-metodos-alternativos-aos-testes-de-cosmeticos-em-animais\/\" target=\"_self\" title=\"News: M\u00e9todos alternativos aos testes de cosm\u00e9ticos em animais ganham for\u00e7a\">\n          \n            <img loading=\"lazy\" decoding=\"async\" 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A Sobel oferece suporte especializado em conformidade com o EU MDR e CE Marking. <\/p>\n","protected":false},"author":11,"featured_media":4684,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7798","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Registro de dispositivos m\u00e9dicos na Europa | MDR e CE Mark<\/title>\n<meta name=\"description\" content=\"Quer fazer o registro de dispositivos m\u00e9dicos na Europa? 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