{"id":26044,"date":"2026-01-09T16:54:30","date_gmt":"2026-01-09T19:54:30","guid":{"rendered":"https:\/\/sobelconsult.com\/our-solutions-canada\/material-characterization-canada\/"},"modified":"2026-01-09T17:03:15","modified_gmt":"2026-01-09T20:03:15","slug":"material-characterization-canada","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/suporte-regulatorio-health-canada\/material-characterization-canada\/","title":{"rendered":"MED CAN MAT C"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"26044\" class=\"elementor elementor-26044\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-277a599 e-flex e-con-boxed e-con e-parent\" data-id=\"277a599\" 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-fff8f62 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"fff8f62\" 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\">Caracteriza\u00e7\u00e3o de materiais (MAT C) para dispositivos m\u00e9dicos<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1bda098 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"1bda098\" 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\":\"For medical devices commercialized in Canada, material-related risks must be identified, understood, and justified. A structured Material Characterization (MAT C) supports this requirement by documenting device materials, processes, and relevant physical characteristics in line with ISO 10993-1.\"}]\" data-inline-monday=\"true\">Para dispositivos m\u00e9dicos comercializados no Canad\u00e1, os riscos relacionados ao material devem ser identificados, compreendidos e justificados. Uma Caracteriza\u00e7\u00e3o de Material (MAT C) estruturada d\u00e1 suporte a esse requisito, documentando os materiais, os processos e as caracter\u00edsticas f\u00edsicas relevantes do dispositivo, de acordo com a norma ISO 10993-1. <\/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-ccd9625 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"ccd9625\" 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=\"#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\">Tenha suporte especializado<\/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-889851d e-flex e-con-boxed e-con e-parent\" data-id=\"889851d\" 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<div class=\"elementor-element elementor-element-612ae68 e-con-full e-flex e-con e-child\" data-id=\"612ae68\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-6f085f0 e-con-full e-transform e-flex e-con e-child\" data-id=\"6f085f0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8338bf1 elementor-widget elementor-widget-heading\" data-id=\"8338bf1\" 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<span class=\"elementor-heading-title elementor-size-default\">Para quem?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7102573 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7102573\" 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-78ff131 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78ff131\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricantes de dispositivos m\u00e9dicos das classes I, II, III e IV<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que preparam documenta\u00e7\u00e3o relacionada a materiais para apoiar a avalia\u00e7\u00e3o biol\u00f3gica<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Equipes t\u00e9cnicas e regulat\u00f3rias que exigem documenta\u00e7\u00e3o estruturada de caracteriza\u00e7\u00e3o de materiais<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricantes com dispositivos que envolvem materiais, processos ou etapas de esteriliza\u00e7\u00e3o complexos<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que preparam documenta\u00e7\u00e3o para mercados regulamentados que reconhecem as normas ISO 10993<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\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<\/div>\n\t\t<div class=\"elementor-element elementor-element-2180525 e-con-full e-flex e-con e-child\" data-id=\"2180525\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-84764bb elementor-widget elementor-widget-image\" data-id=\"84764bb\" 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 fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18566\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-99f7e3d e-flex e-con-boxed e-con e-parent\" data-id=\"99f7e3d\" 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-4129d65 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"4129d65\" 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\":\"Sobel supports manufacturers by preparing structured Material Characterization (MAT C) Reports aligned with ISO 10993-1, supporting biological safety evaluation and downstream risk assessments.\"}]\" data-inline-monday=\"true\">A Sobel d\u00e1 suporte aos fabricantes preparando relat\u00f3rios estruturados de caracteriza\u00e7\u00e3o de materiais (MAT C) alinhados com a norma ISO 10993-1, apoiando a avalia\u00e7\u00e3o de seguran\u00e7a biol\u00f3gica e as avalia\u00e7\u00f5es de risco posteriores.<\/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-63304d7 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"63304d7\" 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=\"#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-99708fc e-flex e-con-boxed e-con e-parent\" data-id=\"99708fc\" 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-f14dc2e elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"f14dc2e\" 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 decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.webp\" class=\"attachment-full size-full wp-image-18572\" alt=\"Vector rectangle blue\" \/>\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-4a74f24 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"4a74f24\" 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\">Por que voc\u00ea precisa desse servi\u00e7o?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-147f5f5 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"147f5f5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-63c6567 e-con-full e-flex e-con e-child\" data-id=\"63c6567\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43c4666 elementor-widget elementor-widget-text-editor\" data-id=\"43c4666\" 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\":\"Material characterization provides structured identification and documentation of device materials, manufacturing processes, and relevant physical characteristics.\"}]\" data-inline-monday=\"true\">A caracteriza\u00e7\u00e3o de materiais fornece identifica\u00e7\u00e3o estruturada e documenta\u00e7\u00e3o de materiais de dispositivos, processos de fabrica\u00e7\u00e3o e caracter\u00edsticas f\u00edsicas relevantes.<\/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<div class=\"elementor-element elementor-element-63a16c8 e-con-full e-flex e-con e-child\" data-id=\"63a16c8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37fd5e2 elementor-widget elementor-widget-text-editor\" data-id=\"37fd5e2\" 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\":\"It supports risk analysis by linking materials, processing steps, and potential chemical exposure scenarios.\"}]\" data-inline-monday=\"true\">Ele oferece suporte \u00e0 an\u00e1lise de risco ao vincular materiais, etapas de processamento e poss\u00edveis cen\u00e1rios de exposi\u00e7\u00e3o a produtos qu\u00edmicos.<\/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<div class=\"elementor-element elementor-element-b45a59c e-con-full e-flex e-con e-child\" data-id=\"b45a59c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f6e1cce elementor-widget elementor-widget-text-editor\" data-id=\"f6e1cce\" 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\":\"A clear MAT C report forms the basis for biological evaluation and toxicological risk assessment when required.\"}]\" data-inline-monday=\"true\">Um relat\u00f3rio MAT C claro forma a base para a avalia\u00e7\u00e3o biol\u00f3gica e a avalia\u00e7\u00e3o de risco toxicol\u00f3gico, quando 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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-48c6a52 e-flex e-con-boxed e-con e-parent\" data-id=\"48c6a52\" 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-4470ae4 e-con-full e-flex e-con e-child\" data-id=\"4470ae4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49ddae8 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"49ddae8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" 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\">A seguran\u00e7a come\u00e7a no n\u00edvel do material<\/h3>\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-3d2cbe6 e-con-full e-flex e-con e-child\" data-id=\"3d2cbe6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b923019 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b923019\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&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\":\"ISO 10993-1 requires manufacturers to understand and document the materials used in a medical device, how they are processed, and how they may contribute to patient or user exposure. Sobel delivers structured material characterization services based on device classification and regulatory expectations.\"}]\" data-inline-monday=\"true\">A ISO 10993-1 exige que os fabricantes compreendam e documentem os materiais usados em um dispositivo m\u00e9dico, como eles s\u00e3o processados e como podem contribuir para a exposi\u00e7\u00e3o do paciente ou do usu\u00e1rio. A Sobel oferece servi\u00e7os estruturados de caracteriza\u00e7\u00e3o de materiais com base na classifica\u00e7\u00e3o de dispositivos e nas expectativas regulat\u00f3rias. <\/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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-00cc883 e-flex e-con-boxed e-con e-parent\" data-id=\"00cc883\" 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-e00efa8 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e00efa8\" 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\">A caracteriza\u00e7\u00e3o estruturada do material oferece suporte a decis\u00f5es de seguran\u00e7a defens\u00e1veis.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b70b00a elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"b70b00a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\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\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_b70b00a *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_b70b00a .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b70b00a  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_b70b00a  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet i, #uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_b70b00a\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_b70b00a\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ae303a4\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Definir o escopo<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Com base na classe do seu dispositivo (I-IV), na documenta\u00e7\u00e3o dispon\u00edvel e nos objetivos do projeto, alinhamos o escopo de caracteriza\u00e7\u00e3o de material mais adequado de acordo com a ISO 10993-1.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-f327a09\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Compartilhe informa\u00e7\u00f5es<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Voc\u00ea fornece a documenta\u00e7\u00e3o dispon\u00edvel sobre materiais de dispositivos, processos de fabrica\u00e7\u00e3o, embalagem\/esteriliza\u00e7\u00e3o (quando aplic\u00e1vel) e configura\u00e7\u00e3o do produto.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-a145d0a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Avalia\u00e7\u00e3o t\u00e9cnica<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nossos especialistas realizam o escopo acordado e entregam um Relat\u00f3rio de Caracteriza\u00e7\u00e3o de Material (MAT C) estruturado, alinhado com os requisitos da ISO 10993-1 e com o contexto do seu dispositivo.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-f2b4d0e\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Relat\u00f3rio<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">A documenta\u00e7\u00e3o resultante d\u00e1 suporte \u00e0s atividades de avalia\u00e7\u00e3o biol\u00f3gica, \u00e0 an\u00e1lise de risco relacionada ao material e \u00e0 tomada de decis\u00e3o baseada em risco em todo o seu caminho regulat\u00f3rio.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6828b0 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"d6828b0\" 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<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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-762ac84 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"762ac84\" 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-2046434 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"2046434\" 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\">Qual servi\u00e7o se aplica ao seu dispositivo m\u00e9dico?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ee72a1 elementor-widget elementor-widget-text-editor\" data-id=\"5ee72a1\" 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\":\"When preparing material-related documentation for medical devices, manufacturers can follow two distinct material characterization pathways, depending on device classification and regulatory expectations. Both approaches are aligned with ISO 10993-1 and designed to support biological safety evaluation:\"}]\" data-inline-monday=\"true\">Ao preparar a documenta\u00e7\u00e3o relacionada a materiais para dispositivos m\u00e9dicos, os fabricantes podem seguir dois caminhos distintos de caracteriza\u00e7\u00e3o de materiais, dependendo da classifica\u00e7\u00e3o do dispositivo e das expectativas regulat\u00f3rias. Ambas as abordagens est\u00e3o alinhadas com a ISO 10993-1 e foram projetadas para dar suporte \u00e0 avalia\u00e7\u00e3o de seguran\u00e7a biol\u00f3gica: <\/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-1fab86c e-flex e-con-boxed e-con e-child\" data-id=\"1fab86c\" 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-3ede3af e-con-full e-flex e-con e-child\" data-id=\"3ede3af\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed3d6f9 elementor-widget elementor-widget-heading\" data-id=\"ed3d6f9\" 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\">Caracteriza\u00e7\u00e3o de materiais (MAT C) - Classes I e II<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ec1cf9 elementor-widget elementor-widget-text-editor\" data-id=\"1ec1cf9\" 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\":\"For Class I and II medical devices, material characterization focuses on documenting device materials, manufacturing processes, and relevant physical characteristics to support material-related risk identification. The assessment is structured to reflect the device context, intended use, and exposure considerations, providing a clear technical foundation to support biological evaluation and downstream safety decisions.\"}]\" data-inline-monday=\"true\">Para os dispositivos m\u00e9dicos de Classe I e II, a caracteriza\u00e7\u00e3o do material se concentra na documenta\u00e7\u00e3o dos materiais do dispositivo, nos processos de fabrica\u00e7\u00e3o e nas caracter\u00edsticas f\u00edsicas relevantes para apoiar a identifica\u00e7\u00e3o dos riscos relacionados ao material. A avalia\u00e7\u00e3o \u00e9 estruturada para refletir o contexto do dispositivo, o uso pretendido e as considera\u00e7\u00f5es de exposi\u00e7\u00e3o, fornecendo uma base t\u00e9cnica clara para apoiar a avalia\u00e7\u00e3o biol\u00f3gica e as decis\u00f5es de seguran\u00e7a posteriores. <\/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<div class=\"elementor-element elementor-element-85316ee e-con-full e-flex e-con e-child\" data-id=\"85316ee\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee126ee elementor-widget elementor-widget-heading\" data-id=\"ee126ee\" 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\">Caracteriza\u00e7\u00e3o de materiais (MAT C) - Classes III e IV<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7262a63 elementor-widget elementor-widget-text-editor\" data-id=\"7262a63\" 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\":\"For Class III and IV medical devices, material characterization follows the same ISO 10993-1 framework while addressing the higher level of scrutiny typically associated with increased risk classification. The documentation provides structured visibility into materials, processes, and relevant chemical and physical characteristics, supporting a more robust risk analysis and biological safety strategy.\"}]\" data-inline-monday=\"true\">Para os dispositivos m\u00e9dicos de Classe III e IV, a caracteriza\u00e7\u00e3o do material segue a mesma estrutura da ISO 10993-1 e, ao mesmo tempo, aborda o n\u00edvel mais alto de escrut\u00ednio normalmente associado a uma classifica\u00e7\u00e3o de risco maior. A documenta\u00e7\u00e3o oferece visibilidade estruturada dos materiais, processos e caracter\u00edsticas qu\u00edmicas e f\u00edsicas relevantes, dando suporte a uma an\u00e1lise de risco mais robusta e a uma estrat\u00e9gia de seguran\u00e7a biol\u00f3gica. <\/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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dfd9bc8 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-con-full e-flex e-con e-child\" data-id=\"dfd9bc8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-482ac5c e-con-full e-flex e-con e-child\" data-id=\"482ac5c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93d6300 elementor-widget elementor-widget-heading\" data-id=\"93d6300\" 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\">RDC 848\/2024 Treinamento<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7007d35 elementor-widget elementor-widget-text-editor\" data-id=\"7007d35\" 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\":\"RDC 848\/2024 replaces RDC 546\/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation\u2019s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.\"}]\" data-inline-monday=\"true\">A RDC 848\/2024 substitui a RDC 546\/2021 e introduz requisitos atualizados de seguran\u00e7a e desempenho para dispositivos m\u00e9dicos, IVDs e software. Este treinamento explica o impacto da regulamenta\u00e7\u00e3o sobre fabricantes e importadores, abordando os requisitos fundamentais que devem ser atendidos para o acesso ao mercado no Brasil. <\/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<div class=\"elementor-element elementor-element-c95cea7 e-con-full e-flex e-con e-child\" data-id=\"c95cea7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc99b20 elementor-widget elementor-widget-heading\" data-id=\"fc99b20\" 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\">Treinamento MDR 2017\/745<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-393d581 elementor-widget elementor-widget-text-editor\" data-id=\"393d581\" 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\":\"The European Medical Device Regulation (MDR 2017\/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.\"}]\" data-inline-monday=\"true\">O Regulamento Europeu de Dispositivos M\u00e9dicos (MDR 2017\/745) representa uma das estruturas mais abrangentes e complexas do mundo. Este treinamento oferece uma vis\u00e3o geral dos requisitos do MDR, incluindo classifica\u00e7\u00e3o, rotas de avalia\u00e7\u00e3o de conformidade, documenta\u00e7\u00e3o t\u00e9cnica e obriga\u00e7\u00f5es de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o, ajudando as empresas a se prepararem para a conformidade com a UE. <\/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<div class=\"elementor-element elementor-element-cd5f9a1 e-con-full e-flex e-con e-child\" data-id=\"cd5f9a1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-257cc1a elementor-widget elementor-widget-heading\" data-id=\"257cc1a\" 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\">Treinamento em ISO 10993<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc47362 elementor-widget elementor-widget-text-editor\" data-id=\"fc47362\" 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\":\"ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.\"}]\" data-inline-monday=\"true\">A ISO 10993 \u00e9 a norma internacional para avalia\u00e7\u00e3o biol\u00f3gica, que estabelece como avaliar a biocompatibilidade e a seguran\u00e7a de dispositivos m\u00e9dicos. Esse treinamento garante que a sua equipe compreenda as \u00faltimas atualiza\u00e7\u00f5es da norma, como elaborar planos de avalia\u00e7\u00e3o biol\u00f3gica e como evitar atrasos dispendiosos nas submiss\u00f5es regulamentares. <\/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<div class=\"elementor-element elementor-element-3f4dd7c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-heading\" data-id=\"3f4dd7c\" 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\">Voc\u00ea n\u00e3o tem certeza de como registrar seu produto de dispositivo m\u00e9dico na Anvisa?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ede5b45 elementor-widget elementor-widget-text-editor\" data-id=\"ede5b45\" 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=\"[{\"attributes\":{\"bold\":true},\"insert\":\"If you are unsure which material characterization pathway best fits your device, Sobel can help you identify the most appropriate scenario based on your device classification, available documentation, and regulatory objectives.\"}]\" data-inline-monday=\"true\">Se voc\u00ea n\u00e3o tiver certeza de qual caminho de caracteriza\u00e7\u00e3o de material \u00e9 mais adequado para o seu dispositivo, a Sobel pode ajud\u00e1-lo a identificar o cen\u00e1rio mais apropriado com base na classifica\u00e7\u00e3o do dispositivo, na documenta\u00e7\u00e3o dispon\u00edvel e nos objetivos regulat\u00f3rios.<\/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-b229f62 e-flex e-con-boxed e-con e-parent\" data-id=\"b229f62\" 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<div class=\"elementor-element elementor-element-6cb7972 e-con-full e-flex e-con e-child\" data-id=\"6cb7972\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-00a725b elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"00a725b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" 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-2d5bca8 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2d5bca8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&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\">Servi\u00e7os relacionados <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e316979 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e316979\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&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\":\"Material characterization is a fundamental step in demonstrating the chemical safety of medical devices. Depending on your device and regulatory strategy, you may also require:\"}]\" data-inline-monday=\"true\">A caracteriza\u00e7\u00e3o de materiais \u00e9 uma etapa fundamental para demonstrar a seguran\u00e7a qu\u00edmica dos dispositivos m\u00e9dicos. Dependendo do seu dispositivo e da estrat\u00e9gia regulat\u00f3ria, voc\u00ea tamb\u00e9m pode precisar: <\/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<div class=\"elementor-element elementor-element-b0cd08f e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"b0cd08f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-fe00e35 e-con-full e-flex e-con e-child\" data-id=\"fe00e35\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7dc7886 elementor-widget elementor-widget-heading\" data-id=\"7dc7886\" 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\">Avalia\u00e7\u00e3o biol\u00f3gica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc763af elementor-widget elementor-widget-text-editor\" data-id=\"fc763af\" 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\":\"Expert ISO 10993 biological evaluations for biocompatibility, safety, and regulatory success.\"}]\" data-inline-monday=\"true\">Avalia\u00e7\u00f5es biol\u00f3gicas especializadas conforme ISO 10993 para biocompatibilidade, seguran\u00e7a e sucesso regulat\u00f3rio.<\/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-90bdbe2 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"90bdbe2\" 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=\"#footer-cta\" target=\"_blank\">\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\">Entre em contato conosco<\/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-60687e1 e-con-full e-flex e-con e-child\" data-id=\"60687e1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a0ae53 elementor-widget elementor-widget-heading\" data-id=\"6a0ae53\" 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\">Avalia\u00e7\u00e3o de risco toxicol\u00f3gico<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40c6529 elementor-widget elementor-widget-text-editor\" data-id=\"40c6529\" 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<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"TRA aligned with ISO 10993-18 and Health Canada expectations.\"}]\" data-inline-monday=\"true\">TRA alinhado com as expectativas da ISO 10993-18 e da Health Canada.<\/p><\/div><\/div><\/div><\/div>\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-4d050cc elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4d050cc\" 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=\"#footer-cta\" target=\"_blank\">\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\">Entre em contato conosco<\/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-d66731b e-con-full e-flex e-con e-child\" data-id=\"d66731b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f251aed elementor-widget elementor-widget-heading\" data-id=\"f251aed\" 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\">Elabora\u00e7\u00e3o de documenta\u00e7\u00e3o t\u00e9cnica para Health Canada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af6bdf1 elementor-widget elementor-widget-text-editor\" data-id=\"af6bdf1\" 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\":\"Guidance to structure technical documentation for regulatory submissions.\"}]\" data-inline-monday=\"true\">Orienta\u00e7\u00e3o para estruturar a documenta\u00e7\u00e3o t\u00e9cnica para submiss\u00f5es regulat\u00f3rias.<\/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-6d62746 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6d62746\" 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=\"#footer-cta\" target=\"_blank\">\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\">Entre em contato conosco<\/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\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-62e60c9 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"62e60c9\" 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<div class=\"elementor-element elementor-element-fcabdd7 e-con-full e-flex e-con e-child\" data-id=\"fcabdd7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a6a9c47 e-con-full e-flex e-con e-child\" data-id=\"a6a9c47\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-399ea4c elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"399ea4c\" 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\">Da caracteriza\u00e7\u00e3o de materiais \u00e0 justificativa de seguran\u00e7a qu\u00edmica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-130a391 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"130a391\" 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\":\"A structured material characterization is essential to understand your device materials, support risk analysis, and enable downstream biological and toxicological assessments. Talk to Sobel and ensure your MAT C documentation is clear, traceable, and aligned with ISO 10993-1 expectations.\"}]\" data-inline-monday=\"true\">Uma caracteriza\u00e7\u00e3o de material estruturada \u00e9 essencial para que voc\u00ea entenda os materiais de seus dispositivos, d\u00ea suporte \u00e0 an\u00e1lise de risco e permita avalia\u00e7\u00f5es biol\u00f3gicas e toxicol\u00f3gicas posteriores. Fale com a Sobel e garanta que sua documenta\u00e7\u00e3o MAT C seja clara, rastre\u00e1vel e alinhada com as expectativas da ISO 10993-1. <\/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 class=\"elementor-element elementor-element-a0aead1 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a0aead1\" 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<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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0be8334 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"0be8334\" 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-01cb405 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"01cb405\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1881\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1881\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Voc\u00ea ainda tem d\u00favidas? D\u00ea uma olhada em nosso FAQ. <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1881\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1881\"><p><b>1. A caracteriza\u00e7\u00e3o de materiais \u00e9 obrigat\u00f3ria para dispositivos m\u00e9dicos no Canad\u00e1?<\/b><\/p>\n<p>Espera-se que os fabricantes demonstrem uma compreens\u00e3o clara dos materiais dos dispositivos e seu poss\u00edvel impacto na seguran\u00e7a do paciente como parte da avalia\u00e7\u00e3o biol\u00f3gica. A caracteriza\u00e7\u00e3o de materiais \u00e9 uma forma comumente aceita de apoiar essa expectativa. <\/p>\n<p><b>2. Quais classes de dispositivos normalmente exigem a caracteriza\u00e7\u00e3o do material?<\/b><\/p>\n<p>A caracteriza\u00e7\u00e3o do material pode ser aplic\u00e1vel a dispositivos m\u00e9dicos de todas as classes (I-IV), dependendo da composi\u00e7\u00e3o do material, do contato com o corpo e da dura\u00e7\u00e3o da exposi\u00e7\u00e3o. A profundidade da documenta\u00e7\u00e3o normalmente aumenta com a classifica\u00e7\u00e3o de risco do dispositivo. <\/p>\n<p><b>3. O MAT C est\u00e1 alinhado com os padr\u00f5es ISO aceitos pelo Minist\u00e9rio da Sa\u00fade do Canad\u00e1?<\/b><\/p>\n<p>Sim. O MAT C foi desenvolvido de acordo com a ISO 10993-1, que \u00e9 reconhecida internacionalmente e comumente aceita pelo Minist\u00e9rio da Sa\u00fade do Canad\u00e1 para avalia\u00e7\u00e3o da seguran\u00e7a biol\u00f3gica. <\/p>\n<p><b>4. A caracteriza\u00e7\u00e3o do material inclui avalia\u00e7\u00e3o de risco toxicol\u00f3gico?<\/b><\/p>\n<p>N\u00e3o. A avalia\u00e7\u00e3o de risco toxicol\u00f3gico (ART) n\u00e3o faz parte do servi\u00e7o MAT C. Voc\u00ea pode contar com o apoio da Sobel para essa etapa. No entanto, voc\u00ea pode contar com a Sobel para dar suporte a essa etapa tamb\u00e9m, com a TRA conduzida por especialistas experientes.  <\/p>\n<p><b>5. Esse servi\u00e7o \u00e9 adequado para empresas localizadas fora do Canad\u00e1?<\/b><\/p>\n<p>Sim. A Sobel d\u00e1 suporte a fabricantes canadenses e internacionais que preparam dispositivos m\u00e9dicos para o mercado canadense. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Caracteriza\u00e7\u00e3o de materiais (MAT C) para dispositivos m\u00e9dicos Para dispositivos m\u00e9dicos comercializados no Canad\u00e1, os riscos relacionados ao material devem ser identificados, compreendidos e justificados. Uma Caracteriza\u00e7\u00e3o de Material (MAT C) estruturada d\u00e1 suporte a esse requisito, documentando os materiais, os processos e as caracter\u00edsticas f\u00edsicas relevantes do dispositivo, de acordo com a norma ISO [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":8432,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-26044","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Caracteriza\u00e7\u00e3o de Materiais (MAT C) para Dispositivos M\u00e9dicos | Canad\u00e1<\/title>\n<meta name=\"description\" content=\"Caracteriza\u00e7\u00e3o de materiais (MAT C) para dispositivos m\u00e9dicos em prepara\u00e7\u00e3o para o mercado canadense, alinhado com a ISO 10993-1.\" \/>\n<meta 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