{"id":21758,"date":"2025-11-27T17:37:02","date_gmt":"2025-11-27T20:37:02","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/iso-10993-12025-guide\/"},"modified":"2026-11-12T05:20:26","modified_gmt":"2026-11-12T08:20:26","slug":"guia-iso-10993-1-2025-anvisa","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/materiais\/guia-iso-10993-1-2025-anvisa\/","title":{"rendered":"Guia ISO 10993-1:2025 e a Anvisa | E-book gratuito"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"21758\" class=\"elementor elementor-21758 elementor-21745\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-245b06b e-con-boxed e-flex e-con e-parent\" data-id=\"245b06b\" data-element_type=\"container\" data-e-type=\"container\" id=\"top\" 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-4900f59 e-con-full e-flex e-con e-child\" data-id=\"4900f59\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d1629a9 elementor-widget elementor-widget-heading\" data-id=\"d1629a9\" 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<p class=\"elementor-heading-title elementor-size-default\">E-book gratuito \u00b7 <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33b4238 elementor-widget elementor-widget-heading\" data-id=\"33b4238\" 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<h1 class=\"elementor-heading-title elementor-size-default\"><span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span>: o que muda na Anvisa <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ddc041 elementor-widget elementor-widget-html\" data-id=\"2ddc041\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style id=\"sb-ebook-wrap\">.elementor-21745 h1,.elementor-21745 h2,.elementor-21745 h3,.elementor-44479 h1,.elementor-44479 h2,.elementor-44479 h3{text-wrap:balance}<\/style><style id=\"snl-m-hero\">@media(max-width:767px){.elementor-element-2ddc041{text-align:center}.elementor-element-2ddc041 ul{display:none!important}.elementor-element-d1629a9 .elementor-heading-title{justify-content:center}}<\/style><div style=\"display:flex;flex-direction:column;gap:24px;font-family:'Host Grotesk',sans-serif;color:#2B2E34;\"><p style=\"margin: 0; font-size: 19px; line-height: 1.6; max-width: 560px;\">Guia pr\u00e1tico sobre o que mudou na avalia\u00e7\u00e3o biol\u00f3gica de dispositivos m\u00e9dicos e o que revisar no seu dossi\u00ea t\u00e9cnico na Anvisa.<\/p>\n      <ul style=\"margin: 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 12px; font-size: 17px; line-height: 1.5;\">\n        <li style=\"display: flex; gap: 12px; align-items: flex-start;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"22\" height=\"22\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" style=\"flex-shrink: 0; margin-top: 2px;\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>As 8 principais mudan\u00e7as em rela\u00e7\u00e3o \u00e0 edi\u00e7\u00e3o de 2018<\/span><\/li>\n        <li style=\"display: flex; gap: 12px; align-items: flex-start;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"22\" height=\"22\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" style=\"flex-shrink: 0; margin-top: 2px;\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>O que muda na Anvisa, na ABNT NBR, na FDA e na UE<\/span><\/li>\n        <li style=\"display: flex; gap: 12px; align-items: flex-start;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"22\" height=\"22\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" style=\"flex-shrink: 0; margin-top: 2px;\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg><span>Um plano em cinco etapas e uma autoavalia\u00e7\u00e3o<\/span><\/li>\n      <\/ul>\n      <p style=\"margin: 0; font-size: 14px; color: #5A5F6A;\">Guia executivo de 8 p\u00e1ginas \u00b7 PDF \u00b7 Elaborado pela equipe de Evid\u00eancia Cl\u00ednica e Seguran\u00e7a de Produto da Sobel<\/p><\/div>\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-25d6c62 e-con-full e-flex e-con e-child\" data-id=\"25d6c62\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93593f0 elementor-widget elementor-widget-html\" data-id=\"93593f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div style=\"display: flex; gap: 16px; align-items: center; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\">\n  <div aria-hidden=\"true\" style=\"width: 132px; height: 93px; flex-shrink: 0; border-radius: 6px; overflow: hidden; position: relative; background: linear-gradient(135deg, #051B5A 0%, #051B5A 55%, #1B3A8A 100%); box-shadow: 0 10px 24px rgba(7,31,99,0.3); color: #FFFFFF; padding: 10px; box-sizing: border-box; display: flex; flex-direction: column; justify-content: space-between;\">\n    <span style=\"font-weight: 600; font-size: 11px; letter-spacing: .02em;\">Sobel<\/span>\n    <span style=\"display: flex; flex-direction: column; gap: 3px;\"><span style=\"font-family: 'Lora', serif; font-weight: 600; font-size: 12px; line-height: 1.1;\"><span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span><\/span><span style=\"font-size: 7.5px; line-height: 1.25; opacity: .9;\">O novo panorama da avalia\u00e7\u00e3o biol\u00f3gica<\/span><\/span>\n    <span style=\"position: absolute; left: 0; right: 0; bottom: 0; height: 4px; background: #F2B705;\"><\/span>\n  <\/div>\n  <div style=\"display: flex; flex-direction: column; gap: 4px;\">\n    <p style=\"margin: 0; font-family: 'Lora', serif; font-weight: 600; font-size: 22px; line-height: 1.2; color: #051B5A;\">Baixe o guia gratuito<\/p>\n    <p style=\"margin: 0; font-size: 14px; line-height: 1.45; color: #5A5F6A;\">Enviamos o PDF direto para o seu e-mail.<\/p>\n  <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a806483 elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"a806483\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Pr\\u00f3ximo&quot;,&quot;step_previous_label&quot;:&quot;Anterior&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_lp_LP_EBOOK_ISO_ENG\" name=\"Formul\u00e1rio de contato - LP_EBOOK_ISO_ENG\" aria-label=\"Formul\u00e1rio de contato - LP_EBOOK_ISO_ENG\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"21758\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"a806483\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNome completo\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Seu nome\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEmpresa\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Nome da empresa\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tE-mail corporativo\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"nome@empresa.com.br\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-device_stage elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-device_stage\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEm que momento est\u00e1 o seu dispositivo?\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-caret-down\" viewBox=\"0 0 571.4 571.4\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M571 393Q571 407 561 418L311 668Q300 679 286 679T261 668L11 418Q0 407 0 393T11 368 36 357H536Q550 357 561 368T571 393Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[device_stage]\" id=\"form-field-device_stage\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">Selecione uma op\u00e7\u00e3o<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Em desenvolvimento\">Em desenvolvimento<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"J\u00e1 regularizado na Anvisa\">J\u00e1 regularizado na Anvisa<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Preparando notifica\u00e7\u00e3o ou registro\">Preparando notifica\u00e7\u00e3o ou registro<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Respondendo a exig\u00eancia ou auditoria\">Respondendo a exig\u00eancia ou auditoria<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">Concordo com a pol\u00edtica de privacidade e autorizo o envio do guia e de atualiza\u00e7\u00f5es regulat\u00f3rias ocasionais da Sobel.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-origem_lead elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[origem_lead]\" id=\"form-field-origem_lead\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" value=\"lp-ebook-eng\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\" id=\"btn_LP_EBOOK_ISO_ENG\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Quero receber o guia<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\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-e18b49b elementor-widget elementor-widget-html\" data-id=\"e18b49b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<link data-minify=\"1\" rel=\"stylesheet\" href=\"https:\/\/ciparoni.com\/wp-content\/cache\/background-css\/1\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css?ver=1760368402&wpr_t=1760357602\">\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js?ver=1760368402\"><\/script>\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/jquery\/3.7.1\/jquery.min.js?ver=1760368402\"><\/script>\r\n\r\n<script>\r\n    const phoneInputField = document.querySelectorAll('input[type=\"tel\"]');\r\n    const btForm = document.querySelectorAll('.elementor-button[type=\"submit\"]');\r\n    let telefones = [];\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var phone_number = window.intlTelInput(phoneInputField[i], {\r\n        separateDialCode: true,\r\n        preferredCountries:[\"br\",\"us\", \"de\", \"fr\" ],\r\n        hiddenInput: \"full\",\r\n        utilsScript: \"\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n        });\r\n\r\n        telefones[i] = phone_number;\r\n    }\r\n    $(phoneInputField).each(function(i) {\r\n     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data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e5e500 elementor-widget elementor-widget-html\" data-id=\"3e5e500\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<section style=\"background: #FFFFFF; padding: 40px 20px; border-top: 1px solid #E8E4DF; border-bottom: 1px solid #E8E4DF;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-direction: column; gap: 24px; align-items: center;\">\n    <p style=\"margin: 0; font-size: 14px; letter-spacing: 1px; text-transform: uppercase; color: #5A5F6A;\">A confian\u00e7a de fabricantes no Brasil e no exterior<\/p>\n    <div style=\"display: flex; flex-wrap: wrap; gap: 12px 32px; justify-content: center; font-size: 15px; color: #051B5A; font-weight: 500;\">\n      <span>Certificada ISO 9001 no Brasil<\/span> <span aria-hidden=\"true\" style=\"color: #F2B705;\">\u2022<\/span> <span>Top Medical Device Regulatory Consultant \u00b7 Am\u00e9rica Latina 2025<\/span> <span aria-hidden=\"true\" style=\"color: #F2B705;\">\u2022<\/span> <span>Anvisa \u00b7 FDA \u00b7 MDR\/IVDR (UE)<\/span>\n    <\/div>\n  <\/div>\n<\/section>\n\n<section class=\"sb-wc\" style=\"padding: 72px 20px 0;\"><div class=\"sb-wc-grid\" style=\"max-width: 1200px; margin: 0 auto; display: grid; grid-template-columns: minmax(0,1fr) 380px; gap: 56px; align-items: center; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\"><div style=\"display: flex; flex-direction: column; gap: 16px;\">\n    <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>O que muda<\/p>\n    <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">O que muda na <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span><\/h2>\n    <p style=\"max-width: 760px; margin: 0; font-size: 18px; line-height: 1.65;\"><span style=\"white-space:nowrap\">A ISO 10993-1:2025<\/span> \u00e9 a sexta edi\u00e7\u00e3o da norma para a avalia\u00e7\u00e3o biol\u00f3gica de dispositivos m\u00e9dicos. Ela reorganiza a avalia\u00e7\u00e3o biol\u00f3gica com base no processo de gest\u00e3o de riscos <strong>da ISO 14971<\/strong>, introduz novas <strong>categorias de contato com o corpo<\/strong> e uma forma mais clara de calcular <strong>os dias de contato<\/strong>, substitui a \u00fanica Tabela A.1 por quatro tabelas de efeitos biol\u00f3gicos e refor\u00e7a o papel da <strong>caracteriza\u00e7\u00e3o qu\u00edmica<\/strong>, <strong>da bioacumula\u00e7\u00e3o<\/strong> e das alternativas aos testes em animais, de acordo com os <strong>3Rs<\/strong>. <\/p>\n    <p style=\"max-width: 760px; margin: 0; font-size: 18px; line-height: 1.65;\">No Brasil, a ABNT j\u00e1 publicou a nova edi\u00e7\u00e3o como <strong>ABNT NBR ISO 10993-1<\/strong>. Na Anvisa, a avalia\u00e7\u00e3o biol\u00f3gica faz parte do dossi\u00ea t\u00e9cnico e da comprova\u00e7\u00e3o dos requisitos essenciais de seguran\u00e7a e desempenho (RDC 751\/2022 e RDC 848\/2024). <span style=\"white-space:nowrap\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/abnt-nbr-iso-10993-1-anvisa-informacao\/\" style=\"color: #051B5A; font-weight: 600;\">Veja o que isso muda nos seus processos na Anvisa<\/a><\/span>.<\/p>\n  <\/div><aside class=\"sb-wc-card\" style=\"background:#FAF7F2;border-top:6px solid #F2B705;border-radius:16px;padding:28px 28px 12px;font-family:'Host Grotesk',sans-serif;box-sizing:border-box\"><p style=\"margin:0 0 8px;font-weight:600;font-size:13px;letter-spacing:.16em;text-transform:uppercase;color:#051B5A\">Em resumo<\/p><dl style=\"margin:0\"><div style=\"padding:14px 0;border-bottom:1px solid #E7E1D7\"><dt style=\"font-size:14px;color:#5A5F6A;margin:0 0 4px\">Edi\u00e7\u00e3o<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\">Sexta, publicada em novembro de 2025<\/dd><\/div><div style=\"padding:14px 0;border-bottom:1px solid #E7E1D7\"><dt style=\"font-size:14px;color:#5A5F6A;margin:0 0 4px\">Substitui<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\"><span style=\"white-space:nowrap\">ISO 10993-1:2018<\/span><\/dd><\/div><div style=\"padding:14px 0;border-bottom:1px solid #E7E1D7\"><dt style=\"font-size:14px;color:#5A5F6A;margin:0 0 4px\">No Brasil<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\"><span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span>, setembro de 2026<\/dd><\/div><div style=\"padding:14px 0\"><dt style=\"font-size:14px;color:#5A5F6A;margin:0 0 4px\">No guia<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\">8 mudan\u00e7as e um plano em cinco etapas<\/dd><\/div><\/dl><\/aside><\/div><\/section><style id=\"sb-wc-css\">.sb-wc-grid>div p{max-width:none!important}@media(max-width:1024px){.sb-wc-grid{grid-template-columns:1fr!important;gap:32px!important}}@media(max-width:767px){.sb-wc h2{font-size:30px!important}}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d74fc4e elementor-widget elementor-widget-html\" data-id=\"d74fc4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<section style=\"padding: 72px 20px; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-direction: column; gap: 48px;\">\n    <div style=\"display: flex; flex-direction: column; gap: 20px; max-width: 760px; margin: 0 auto; text-align: center; align-items: center;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>O que tem no guia<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Tudo o que mudou, em um guia pr\u00e1tico<\/h2>\n    <\/div>\n    <div style=\"display: grid; grid-template-columns: repeat(auto-fit, minmax(300px, 1fr)); gap: 20px;\">\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">01<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">A revis\u00e3o de 2025 em resumo<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">Mais integrada ao gerenciamento de risco, mais baseada em risco e voltada ao ciclo de vida: o que isso muda no dia a dia do seu dossi\u00ea.<\/p><\/div>\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">02<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">ISO 14971 e uso indevido previs\u00edvel<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">A avalia\u00e7\u00e3o biol\u00f3gica segue o processo de gest\u00e3o de riscos da norma ISO 14971, incluindo o uso indevido razoavelmente previs\u00edvel.<\/p><\/div>\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">03<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">Categorias de contato e de exposi\u00e7\u00e3o<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">As novas categorias de contato com o corpo e o tempo total de exposi\u00e7\u00e3o em dispositivos com m\u00faltiplos contatos.<\/p><\/div>\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">04<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">Dados qu\u00edmicos e efeitos biol\u00f3gicos<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">O papel da caracteriza\u00e7\u00e3o qu\u00edmica e as quatro tabelas de efeitos biol\u00f3gicos, por tipo de contato com o corpo.<\/p><\/div>\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">05<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">Produtos j\u00e1 regularizados e ciclo de vida<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">O que revisar nos produtos j\u00e1 notificados ou registrados na Anvisa, do desenvolvimento ao fim da vida \u00fatil.<\/p><\/div>\n      <div style=\"background: #FFFFFF; border: 1px solid #E7E1D7; border-top: 4px solid #F2B705; border-radius: 18px; padding: 32px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 28px; color: #F2B705;\">06<\/span><h3 style=\"margin: 0; font-size: 19px; font-weight: 600; color: #051B5A;\">Cinco passos para se preparar<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">Do mapeamento do portf\u00f3lio e das categorias de contato at\u00e9 uma rotina de revis\u00e3o cont\u00ednua.<\/p><\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n<section style=\"padding: 0 20px 72px; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-wrap: wrap; gap: 56px; align-items: center;\">\n    <div style=\"flex: 1 1 320px; display: flex; flex-direction: column; gap: 16px;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Uma pr\u00e9via do guia<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">A tabela de antes e depois para usar no dia a dia<\/h2>\n      <p style=\"margin: 0; font-size: 17px; line-height: 1.6;\">S\u00e3o oito temas, cada um com o que mudou e a a\u00e7\u00e3o esperada. Veja dois deles. <\/p>\n      <a href=\"#cta\" style=\"align-self: flex-start; text-decoration: none; font-weight: 600; font-size: 16px; color: #051B5A; background: #F2B705; border-radius: 999px; padding: 14px 26px; margin-top: 6px;\">Veja os 8 temas no guia<\/a>\n    <\/div>\n    <div style=\"flex: 2 1 560px; min-width: 0; position: relative; padding: 28px 28px 0 0;\">\n      <div aria-hidden=\"true\" style=\"position: absolute; top: 0; right: 0; width: 62%; height: 88%; border-radius: 14px; overflow: hidden; transform: rotate(3deg); box-shadow: 0 20px 50px rgba(7,31,99,0.18);\"><img decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/07\/ebook-iso-10993.webp\" alt=\"\" style=\"width: 100%; height: 100%; object-fit: cover; display: block;\"><\/div>\n      <div style=\"position: relative; background: #FFFFFF; border-radius: 14px; overflow: hidden; border: 1px solid #D9D3CC; box-shadow: 0 24px 60px rgba(7,31,99,0.14); display: grid; grid-template-columns: 150px repeat(3, minmax(0, 1fr)); font-size: 14px; line-height: 1.5;\">\n        <div style=\"background: #051B5A; color: #FFFFFF; padding: 12px 14px; font-weight: 600;\">Tema<\/div>\n        <div style=\"background: #051B5A; color: #FFFFFF; padding: 12px 14px; font-weight: 600;\">2018<\/div>\n        <div style=\"background: #051B5A; color: #FFFFFF; padding: 12px 14px; font-weight: 600;\">2025<\/div>\n        <div style=\"background: #051B5A; color: #F2B705; padding: 12px 14px; font-weight: 600;\">Sua a\u00e7\u00e3o<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; font-weight: 600; color: #051B5A;\">Integra\u00e7\u00e3o com a ISO 14971<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">\u00c9 obrigat\u00f3rio, mas organizado em torno de provas.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">Estruturado com base no processo de gest\u00e3o de riscos da norma ISO 14971.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; background: #FDF0CE; color: #051B5A; font-weight: 500;\">Elaborar o BEP e o BER a partir do gerenciamento de risco.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; font-weight: 600; color: #051B5A;\">Produtos j\u00e1 no mercado<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">A repeti\u00e7\u00e3o do teste j\u00e1 n\u00e3o era obrigat\u00f3ria.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">\u00c9 o mesmo princ\u00edpio, com uma an\u00e1lise documentada dos dados existentes.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; background: #FDF0CE; color: #051B5A; font-weight: 500;\">Verifique se a sua avalia\u00e7\u00e3o ainda \u00e9 v\u00e1lida.<\/div>\n        <div style=\"grid-column: 1 \/ -1; padding: 14px; border-top: 1px dashed #D9D3CC; text-align: center; font-size: 14px; color: #5A5F6A; background: #FAF7F2;\">+ 6 temas no guia<\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/section>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eebf91a elementor-widget elementor-widget-html\" data-id=\"eebf91a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<section style=\"background: #FAF7F2; padding: 72px 20px;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-wrap: wrap; gap: 40px; align-items: flex-start;\">\n    <div style=\"flex: 1 1 320px; display: flex; flex-direction: column; gap: 16px;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Para quem \u00e9<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Para as equipes que respondem pelo dossi\u00ea t\u00e9cnico<\/h2>\n    <\/div>\n    <div style=\"flex: 2 1 520px; display: grid; grid-template-columns: repeat(auto-fit, minmax(240px, 1fr)); gap: 16px;\">\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Fabricantes de dispositivos m\u00e9dicos que entram em contato com o corpo, incluindo dispositivos odontol\u00f3gicos<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Equipes de P&D, Qualidade e Assuntos Regulat\u00f3rios<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Empresas brasileiras que exportam para os EUA e a Europa<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Startups de sa\u00fade (healthtechs e medtechs)<\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n<section id=\"check\" style=\"background: #051B5A; padding: 96px 24px; color: #FFFFFF;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-wrap: wrap; gap: 56px; align-items: center;\">\n    <div style=\"flex: 1 1 420px; display: flex; flex-direction: column; gap: 18px;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #FFFFFF;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Verifica\u00e7\u00e3o r\u00e1pida<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #FFFFFF;\">Tr\u00eas perguntas antes da pr\u00f3xima auditoria ou exig\u00eancia da Anvisa<\/h2>\n      <p style=\"margin: 0; font-size: 18px; line-height: 1.6; color: #DDE2F0;\">Se voc\u00ea responder \u201cn\u00e3o\u201d ou \u201cn\u00e3o tenho certeza\u201d a qualquer uma dessas perguntas, uma breve conversa com a nossa equipe pode te ajudar a planejar os pr\u00f3ximos passos.<\/p>\n      <div style=\"display: flex; flex-wrap: wrap; gap: 14px; margin-top: 8px;\">\n        <a href=\"#footer-cta\" style=\"text-decoration: none; font-weight: 600; font-size: 17px; color: #051B5A; background: #F2B705; border-radius: 999px; padding: 16px 28px;\">Fala com a nossa equipe<\/a>\n        <a href=\"#cta\" style=\"text-decoration: none; font-weight: 500; font-size: 17px; color: #FFFFFF; border: 2px solid #FFFFFF; border-radius: 999px; padding: 14px 26px;\">Pega o guia antes de mais nada<\/a>\n      <\/div>\n    <\/div>\n    <ol style=\"flex: 1 1 420px; margin: 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 14px;\">\n      <li style=\"background: rgba(255,255,255,0.08); border-radius: 12px; padding: 22px 24px; display: flex; gap: 18px; font-size: 18px; line-height: 1.5; color: #FFFFFF;\"><span style=\"font-family: 'Lora', serif; color: #F2B705; font-size: 22px;\">1<\/span><span>O seu Plano de Avalia\u00e7\u00e3o Biol\u00f3gica (BEP) j\u00e1 considera a edi\u00e7\u00e3o de 2025?<\/span><\/li>\n      <li style=\"background: rgba(255,255,255,0.08); border-radius: 12px; padding: 22px 24px; display: flex; gap: 18px; font-size: 18px; line-height: 1.5; color: #FFFFFF;\"><span style=\"font-family: 'Lora', serif; color: #F2B705; font-size: 22px;\">2<\/span><span>A avalia\u00e7\u00e3o biol\u00f3gica est\u00e1 documentada no seu arquivo de gerenciamento de risco (ISO 14971)?<\/span><\/li>\n      <li style=\"background: rgba(255,255,255,0.08); border-radius: 12px; padding: 22px 24px; display: flex; gap: 18px; font-size: 18px; line-height: 1.5; color: #FFFFFF;\"><span style=\"font-family: 'Lora', serif; color: #F2B705; font-size: 22px;\">3<\/span><span>Voc\u00ea consegue justificar cada ensaio realizado e cada ensaio dispensado?<\/span><\/li>\n    <\/ol>\n  <\/div>\n<\/section>\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-a6f32f3 e-flex e-con-boxed e-con e-parent\" data-id=\"a6f32f3\" 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-814624d e-con-full e-flex e-con e-child\" data-id=\"814624d\" 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-492039a elementor-widget elementor-widget-heading\" data-id=\"492039a\" 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<p class=\"elementor-heading-title elementor-size-default\">DEPOIMENTOS<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd18035 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"bd18035\" 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\">Confian\u00e7a para decis\u00f5es que levam produtos adiante.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f361ed2 e-con-full e-flex e-con e-child\" data-id=\"f361ed2\" 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-4dd9fb9 elementor-widget-mobile__width-initial logos-cinza elementor-widget elementor-widget-image-carousel\" data-id=\"4dd9fb9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;5&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay_speed&quot;:1000,&quot;speed&quot;:1000,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;slides_to_show_mobile&quot;:&quot;3&quot;,&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;lazyload&quot;:&quot;yes&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-7-e1785701176338-1-rv1zvwhheyylas12v9wwzjrabfxphtdppkpz3g8f3c.webp\" alt=\"logo-client-sobel-cosmetics-7-e1785701176338.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-2-e1785700906155-1-rv1zvwhheyylas12v9wwzjrabfxphtdppkpz3g8f3c.webp\" alt=\"logo-client-sobel-cosmetics-2-e1785700906155.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-1-e1785700931897-1-rv1zvwhheyylas12v9wwzjrabfxphtdppkpz3g8f3c.webp\" alt=\"logo-client-sobel-cosmetics-1-e1785700931897.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-14-e1785700969629-1-rv1zvwhheyylas12v9wwzjrabfxphtdppkpz3g8f3c.webp\" alt=\"logo-client-sobel-cosmetics-14-e1785700969629.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-12-e1785701037693-1-rv1zvwhheyylas12v9wwzjrabfxphtdppkpz3g8f3c.webp\" alt=\"logo-client-sobel-cosmetics-12-e1785701037693.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-9-e1785701119944-1-rv1zvxfblszvmdzppsbjk1iqwtt2pihg1pdgkq70x4.webp\" alt=\"logo-client-sobel-cosmetics-9-e1785701119944.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-4-e1785701259234-1-rv1zvxfblszvmdzppsbjk1iqwtt2pihg1pdgkq70x4.webp\" alt=\"logo-client-sobel-cosmetics-4-e1785701259234.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/oficial-2-scaled-1-1-rv1zvxfblszvmdzppsbjk1iqwtt2pihg1pdgkq70x4.webp\" alt=\"oficial-2-scaled-1.webp\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/6-1-rv1zvxfblszvmdzppsbjk1iqwtt2pihg1pdgkq70x4.png\" alt=\"6.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/5-1-1-rv1zvyd5sn15xzyckaq64ja7i7ofx7l6du0y205mqw.png\" alt=\"5-1.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"11 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/4-2-1-rv1zvyd5sn15xzyckaq64ja7i7ofx7l6du0y205mqw.png\" alt=\"4-2.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"12 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/3-2-1-rv1zvzazzh2g9lwzet4sp11o3ljt4wowpyofja48ko.png\" alt=\"3-2.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"13 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/2-2-1-rv1zvzazzh2g9lwzet4sp11o3ljt4wowpyofja48ko.png\" alt=\"2-2.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"14 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/1-1-1-rv1zvzazzh2g9lwzet4sp11o3ljt4wowpyofja48ko.png\" alt=\"1-1.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"15 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/9-1-rv1zw08u6b3ql7vm9bjf9it4ozf6clsn23bx0k2ueg.png\" alt=\"9.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"16 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/8-1-rv1zw08u6b3ql7vm9bjf9it4ozf6clsn23bx0k2ueg.png\" alt=\"8.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"17 of 17\"><figure class=\"swiper-slide-inner\"><img class=\"swiper-slide-image swiper-lazy\" data-src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/7-1-rv1zw08u6b3ql7vm9bjf9it4ozf6clsn23bx0k2ueg.png\" alt=\"7.png\" \/><div class=\"swiper-lazy-preloader\"><\/div><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a0dbb5d e-con-full e-flex e-con e-child\" data-id=\"a0dbb5d\" 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-1b4b28b e-con-full e-flex e-con e-child\" data-id=\"1b4b28b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d53ea7d e-con-full e-flex e-con e-child\" data-id=\"d53ea7d\" 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-6103ac8 elementor-widget elementor-widget-heading\" data-id=\"6103ac8\" 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<p class=\"elementor-heading-title elementor-size-default\">\u201c<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7bc2e2a elementor-widget elementor-widget-heading\" data-id=\"7bc2e2a\" 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\">Solu\u00e7\u00f5es r\u00e1pidas, focadas nos seus objetivos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c4b600 elementor-widget elementor-widget-text-editor\" data-id=\"5c4b600\" 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>\u201cA Sobel ofereceu um atendimento pr\u00f3ximo e focado em objetivos, com solu\u00e7\u00f5es r\u00e1pidas. Esperamos trabalhar juntos em novos projetos.\u201d<\/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-79ac680 e-con-full e-flex e-con e-child\" data-id=\"79ac680\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7a0f31d elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"7a0f31d\" 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=\"800\" height=\"800\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1-1024x1024.webp\" class=\"attachment-large size-large wp-image-44837\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1-1024x1024.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/andreas-andratec-sobel-1.webp 1254w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-14c3f35 e-con-full e-flex e-con e-child\" data-id=\"14c3f35\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a7335ac elementor-widget elementor-widget-heading\" data-id=\"a7335ac\" 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<p class=\"elementor-heading-title elementor-size-default\">Andreas Kohl<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-312e18f elementor-widget elementor-widget-text-editor\" data-id=\"312e18f\" 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>CEO \u00b7 Andratec<\/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>\n\t\t<div class=\"elementor-element elementor-element-5ff361c e-con-full e-flex e-con e-child\" data-id=\"5ff361c\" 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-10f72e6 elementor-widget elementor-widget-heading\" data-id=\"10f72e6\" 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<p class=\"elementor-heading-title elementor-size-default\">\u201c<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44864e2 elementor-widget elementor-widget-heading\" data-id=\"44864e2\" 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\">Ampla experi\u00eancia, colabora\u00e7\u00e3o de verdade<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd5015e elementor-widget elementor-widget-text-editor\" data-id=\"cd5015e\" 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>\u201cSempre tive da Sobel Consult uma colabora\u00e7\u00e3o sol\u00edcita e proativa, com alto n\u00edvel de compet\u00eancia em uma ampla gama de temas regulat\u00f3rios.\u201d<\/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-9914f5d e-con-full e-flex e-con e-child\" data-id=\"9914f5d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d2f5b5 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"7d2f5b5\" 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=\"800\" height=\"800\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Mandy-Blocher-1.jpeg\" class=\"attachment-large size-large wp-image-44841\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Mandy-Blocher-1.jpeg 800w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Mandy-Blocher-1-300x300.jpeg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Mandy-Blocher-1-150x150.jpeg 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Mandy-Blocher-1-768x768.jpeg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-f2ca9d8 e-con-full e-flex e-con e-child\" data-id=\"f2ca9d8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-de8101c elementor-widget elementor-widget-heading\" data-id=\"de8101c\" 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<p class=\"elementor-heading-title elementor-size-default\">Mandy Blocher<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98965c5 elementor-widget elementor-widget-text-editor\" data-id=\"98965c5\" 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>Expert Regulatory Framework &#038; Digital Transformation \u00b7 Aesculap AG (B. Braun)<\/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>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-616516e e-con-full e-flex e-con e-child\" data-id=\"616516e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5b1faaf e-con-full e-flex e-con e-child\" data-id=\"5b1faaf\" 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-5d27c10 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"5d27c10\" 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=\"800\" height=\"800\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1-1024x1024.png\" class=\"attachment-large size-large wp-image-44845\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1-1024x1024.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1-150x150.png 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1-768x768.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/2-1-1.png 1080w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-7f9f36c e-con-full e-flex e-con e-child\" data-id=\"7f9f36c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34623ae elementor-widget elementor-widget-heading\" data-id=\"34623ae\" 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<p class=\"elementor-heading-title elementor-size-default\">Direcionamento regulat\u00f3rio claro<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d101f0 elementor-widget elementor-widget-text-editor\" data-id=\"5d101f0\" 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 caminho certo e as prioridades para o seu produto.<\/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-945a543 e-con-full e-flex e-con e-child\" data-id=\"945a543\" 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-f986625 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"f986625\" 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=\"800\" height=\"800\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1-1024x1024.png\" class=\"attachment-large size-large wp-image-44849\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1-1024x1024.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1-150x150.png 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1-768x768.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/3-1-1.png 1080w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-9c540fe e-con-full e-flex e-con e-child\" data-id=\"9c540fe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-13a28ad elementor-widget elementor-widget-heading\" data-id=\"13a28ad\" 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<p class=\"elementor-heading-title elementor-size-default\">Suporte r\u00e1pido e pr\u00f3ximo<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad1c8a7 elementor-widget elementor-widget-text-editor\" data-id=\"ad1c8a7\" 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>Agimos r\u00e1pido para manter seus projetos andando.<\/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-e1b4aa7 e-con-full e-flex e-con e-child\" data-id=\"e1b4aa7\" 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-27f28eb elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"27f28eb\" 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=\"800\" height=\"800\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1-1024x1024.png\" class=\"attachment-large size-large wp-image-44853\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1-1024x1024.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1-150x150.png 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1-768x768.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/4-1-1.png 1080w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-e22903c e-con-full e-flex e-con e-child\" data-id=\"e22903c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-735d54f elementor-widget elementor-widget-heading\" data-id=\"735d54f\" 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<p class=\"elementor-heading-title elementor-size-default\">Orienta\u00e7\u00e3o pr\u00e1tica<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24808d6 elementor-widget elementor-widget-text-editor\" data-id=\"24808d6\" 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>Recomenda\u00e7\u00f5es objetivas para o seu pr\u00f3ximo passo.<\/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>\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-fefdbb1 e-flex e-con-full e-con e-parent\" data-id=\"fefdbb1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b33d22f elementor-widget elementor-widget-html\" data-id=\"b33d22f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<section style=\"background: #FFFFFF; padding: 72px 20px; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-wrap: wrap; gap: 48px; align-items: center;\">\n    <div style=\"flex: 1 1 360px; display: flex; gap: 16px;\">\n      <div style=\"flex: 1; aspect-ratio: 4 \/ 3; border-radius: 16px; overflow: hidden; box-shadow: 0 20px 50px rgba(7,31,99,0.15);\"><img decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/Biological-Evaluation-ISO-10993-1.jpg\" alt=\"Avalia\u00e7\u00e3o biol\u00f3gica de dispositivo m\u00e9dico em laborat\u00f3rio\" loading=\"lazy\" style=\"width: 100%; height: 100%; object-fit: cover; display: block;\"><\/div>\n    <\/div>\n    <div style=\"flex: 1 1 420px; display: flex; flex-direction: column; gap: 18px;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Quem escreveu<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Escrito pela equipe que prepara esses arquivos<\/h2>\n      <p style=\"margin: 0; font-size: 18px; line-height: 1.6;\">Os especialistas da Sobel em assuntos regulat\u00f3rios e seguran\u00e7a biol\u00f3gica preparam a documenta\u00e7\u00e3o de avalia\u00e7\u00e3o biol\u00f3gica para envio \u00e0 ANVISA, \u00e0 FDA e aos organismos notificados da UE, e acompanham como cada autoridade aplica a norma.<\/p>\n    <\/div>\n  <\/div>\n<\/section>\n<section style=\"background: #FAF7F2; padding: 72px 20px; font-family: 'Host Grotesk', sans-serif; color: #2B2E34;\">\n  <div style=\"max-width: 1200px; margin: 0 auto; display: flex; flex-direction: column; gap: 40px;\">\n    <div style=\"display: flex; flex-direction: column; gap: 16px; max-width: 720px;\">\n      <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #051B5A;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Como a Sobel ajuda<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Quando o guia aponta uma lacuna, resolvemos com voc\u00ea<\/h2>\n    <\/div>\n    <div style=\"display: flex; flex-wrap: wrap; gap: 0; align-items: stretch;\">\n      <div style=\"flex: 1 1 260px; min-width: 0; background: #FDF0CE; border: 2px solid #F2B705; border-radius: 16px; padding: 28px; display: flex; flex-direction: column; gap: 12px;\">\n        <span style=\"align-self: flex-start; font-family: 'Host Grotesk', sans-serif; font-size: 12px; font-weight: 600; letter-spacing: 1.6px; text-transform: uppercase; color: #051B5A; background: #F2B705; border-radius: 999px; padding: 6px 12px;\">Voc\u00ea est\u00e1 aqui<\/span>\n        <h3 style=\"margin: 0; font-family: 'Lora', serif; font-size: 24px; font-weight: 500; line-height: 1.2; color: #051B5A;\">Este guia<\/h3>\n        <p style=\"margin: 0; font-size: 16px; line-height: 1.6; color: #2B2E34;\">Entenda as 8 mudan\u00e7as, veja a a\u00e7\u00e3o esperada em cada uma e fa\u00e7a a autoavalia\u00e7\u00e3o do seu dossi\u00ea em cinco etapas.<\/p>\n        <ul style=\"margin: 4px 0 0; padding: 0; list-style: none; display: flex; flex-direction: column; gap: 8px; font-size: 15px; color: #051B5A;\">\n          <li style=\"display: flex; gap: 10px; align-items: center;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"18\" height=\"18\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2.2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg>Tabela de antes e depois<\/li>\n          <li style=\"display: flex; gap: 10px; align-items: center;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"18\" height=\"18\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2.2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg>Vis\u00e3o Brasil (Anvisa), UE e EUA<\/li>\n          <li style=\"display: flex; gap: 10px; align-items: center;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" width=\"18\" height=\"18\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"2.2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 6 9 17l-5-5\"><\/path><\/svg>Autoavalia\u00e7\u00e3o em cinco etapas<\/li>\n        <\/ul>\n      <\/div>\n      <div aria-hidden=\"true\" style=\"flex: 0 0 56px; display: flex; align-items: center; justify-content: center;\">\n        <span style=\"width: 40px; height: 40px; border-radius: 50%; background: #051B5A; display: flex; align-items: center; justify-content: center;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M5 12h14\"><\/path><path d=\"m13 6 6 6-6 6\"><\/path><\/svg><\/span>\n      <\/div>\n      <div style=\"flex: 3 1 640px; min-width: 0; background: #051B5A; border-radius: 16px; padding: 28px; display: flex; flex-direction: column; gap: 20px;\">\n        <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #FFFFFF;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>A partir daqui, a Sobel apoia voc\u00ea<\/p>\n        <div style=\"display: grid; grid-template-columns: repeat(auto-fit, minmax(190px, 1fr)); gap: 14px;\">\n          <div style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); border-radius: 12px; padding: 22px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 22px; color: #F2B705;\">01<\/span><h3 style=\"margin: 0; font-size: 18px; font-weight: 600; color: #FFFFFF;\">An\u00e1lise de lacunas (gap analysis)<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">O seu dossi\u00ea atual comparado com a nova estrutura da <span style=\"white-space:nowrap\">ISO 10993-1<\/span>.<\/p><\/div>\n          <div style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); border-radius: 12px; padding: 22px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 22px; color: #F2B705;\">02<\/span><h3 style=\"margin: 0; font-size: 18px; font-weight: 600; color: #FFFFFF;\">BEP e BER<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">Plano e relat\u00f3rio de avalia\u00e7\u00e3o biol\u00f3gica elaborados ou atualizados com base na ISO 14971 e nos 3Rs.<\/p><\/div>\n          <div style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); border-radius: 12px; padding: 22px; display: flex; flex-direction: column; gap: 10px;\"><span style=\"font-family: 'Lora', serif; font-size: 22px; color: #F2B705;\">03<\/span><h3 style=\"margin: 0; font-size: 18px; font-weight: 600; color: #FFFFFF;\">Treinamento t\u00e9cnico<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">A nova norma, as NAMs e a abordagem baseada em risco para a sua equipe.<\/p><\/div>\n        <\/div>\n        <div style=\"display: flex; flex-wrap: wrap; gap: 16px; align-items: center; justify-content: space-between; border-top: 1px solid rgba(255,255,255,0.18); padding-top: 18px;\">\n          <p style=\"margin: 0; font-size: 16px; color: #DDE2F0;\">N\u00e3o sabe por onde come\u00e7ar? A an\u00e1lise de lacunas costuma ser o primeiro passo. <\/p>\n          <a href=\"#footer-cta\" style=\"text-decoration: none; font-weight: 600; font-size: 17px; color: #051B5A; background: #F2B705; border-radius: 999px; padding: 15px 28px;\">Fale com a nossa equipe<\/a>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/section>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ef3787 elementor-widget elementor-widget-html\" data-id=\"4ef3787\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>\n.sbf{display:flex;flex-wrap:wrap;gap:56px;max-width:1120px;margin:0 auto;padding:72px 24px;box-sizing:border-box;font-family:'Host Grotesk',sans-serif;color:#2B2E34}\n.sbf-intro{flex:1 1 300px;min-width:0;display:flex;flex-direction:column;gap:18px}\n.sbf-eye{margin:0;font-size:13px;font-weight:700;letter-spacing:.14em;color:#051B5A}\n.sbf-eye:before{content:\"\";display:inline-block;width:8px;height:8px;border-radius:50%;background:#F2B705;margin-right:10px;vertical-align:middle}\n.sbf-intro h2{margin:0;font-family:'Lora',Georgia,serif;font-weight:700;font-size:40px;line-height:1.15;color:#051B5A}\n.sbf-intro h2 em{font-style:normal;color:#F2B705}\n.sbf-intro p.sbf-lead{margin:0;font-size:17px;line-height:1.55}\n.sbf-btn{align-self:flex-start;background:#051B5A;color:#fff !important;text-decoration:none;border-radius:999px;padding:14px 26px;font-weight:600;font-size:16px}\n.sbf-btn:hover{background:#0E2C77}\n.sbf-list{flex:2 1 540px;min-width:0;display:flex;flex-direction:column;gap:12px}\n.sbf-item{background:#fff;border:1px solid rgba(5,27,90,.16);border-radius:14px;box-shadow:0 1px 2px rgba(5,27,90,.08);transition:box-shadow .2s}\n.sbf-item[open]{border-left:4px solid #F2B705;box-shadow:0 1px 2px rgba(5,27,90,.10),0 10px 24px rgba(5,27,90,.07)}\n.sbf-item summary{list-style:none;cursor:pointer;display:flex;justify-content:space-between;align-items:center;gap:20px;padding:20px 22px;font-size:17px;font-weight:600;color:#051B5A}\n.sbf-item summary::-webkit-details-marker{display:none}\n.sbf-item summary i{flex:0 0 32px;height:32px;border-radius:50%;border:1.5px solid #D9A400;position:relative}\n.sbf-item summary i:before,.sbf-item summary i:after{content:\"\";position:absolute;left:50%;top:50%;width:12px;height:1.6px;background:#051B5A;transform:translate(-50%,-50%)}\n.sbf-item summary i:after{transform:translate(-50%,-50%) rotate(90deg);transition:transform .2s}\n.sbf-item[open] summary i:after{transform:translate(-50%,-50%) rotate(0deg)}\n.sbf-a{padding:0 22px 20px}\n.sbf-a p{margin:0;font-size:16px;line-height:1.6;color:#2B2E34;max-width:720px}\n.sbf-a a{color:#051B5A}\n@media(max-width:767px){.sbf-intro h2{font-size:32px}.sbf{gap:32px;padding:64px 20px}}\n<\/style>\n<div class=\"sbf\">\n<div class=\"sbf-intro\"><p class=\"sbf-eye\">Perguntas frequentes<\/p><h2>D\u00favidas sobre a <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span> e o <em>guia<\/em><\/h2><p class=\"sbf-lead\">O que os fabricantes costumam perguntar antes de baixar o guia, e o que ele substitui ou n\u00e3o.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Envie sua pergunta \u2192<\/a><\/div>\n<div class=\"sbf-list\">\n<details class=\"sbf-item\" open=\"\"><summary><span>O guia \u00e9 mesmo gratuito?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Sim. Voc\u00ea s\u00f3 informa nome, e-mail corporativo e empresa para que possamos enviar o PDF. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>O que mudou na <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span> em rela\u00e7\u00e3o \u00e0 edi\u00e7\u00e3o de 2018?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>A avalia\u00e7\u00e3o biol\u00f3gica foi reorganizada com base na gest\u00e3o de riscos da norma ISO 14971; as categorias de contato com o corpo e de dura\u00e7\u00e3o foram alteradas; o uso indevido razoavelmente previs\u00edvel passou a fazer parte do escopo; e a Tabela A.1, que antes era \u00fanica, agora se divide em quatro tabelas de efeitos biol\u00f3gicos. O guia aborda todas as oito mudan\u00e7as, indicando a a\u00e7\u00e3o esperada para cada uma delas. <\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Quando foi publicada <span style=\"white-space:nowrap\">a norma ISO 10993-1:2025<\/span> e qual \u00e9 a edi\u00e7\u00e3o brasileira?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>A <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span>, sexta edi\u00e7\u00e3o da norma, foi publicada em novembro de 2025. No Brasil, a ABNT publicou em setembro de 2026 a nova <span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span>, alinhada \u00e0 edi\u00e7\u00e3o de 2025, que substitui a edi\u00e7\u00e3o brasileira de 2022, baseada no texto de 2018. <\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Por onde come\u00e7ar a adequa\u00e7\u00e3o?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Comece por uma an\u00e1lise de lacunas da documenta\u00e7\u00e3o: mapeie seus produtos nas novas categorias de contato, confirme que o Plano (BEP) e o Relat\u00f3rio de Avalia\u00e7\u00e3o Biol\u00f3gica (BER) est\u00e3o integrados ao arquivo de gerenciamento de risco da ISO 14971 e justifique cada ensaio realizado ou dispensado. O guia traz um plano em cinco etapas e uma autoavalia\u00e7\u00e3o. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>Produtos j\u00e1 notificados ou registrados na Anvisa precisam de novos ensaios de biocompatibilidade?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>N\u00e3o automaticamente. A norma n\u00e3o exige que os dispositivos j\u00e1 no mercado, com um perfil de seguran\u00e7a comprovado e aceit\u00e1vel, sejam testados novamente. Uma an\u00e1lise documentada dos dados existentes mostra se s\u00e3o necess\u00e1rios novos dados ou se basta atualizar o BEP e o BER. Uma an\u00e1lise de lacunas responde a essa quest\u00e3o para o seu dispositivo espec\u00edfico.   <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>Quais mercados o guia aborda?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>A norma internacional e o que ela significa no Brasil (ANVISA e a nova <a href=\"https:\/\/sobelconsult.com\/pt-br\/abnt-nbr-iso-10993-1-anvisa-informacao\/\"><span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span><\/a>), na Uni\u00e3o Europeia (MDR) e nos Estados Unidos (FDA).<\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>O guia est\u00e1 atualizado e dispon\u00edvel em portugu\u00eas?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Sim. A vers\u00e3o 1.3 j\u00e1 considera a edi\u00e7\u00e3o brasileira ABNT NBR publicada em setembro de 2026, e o guia est\u00e1 dispon\u00edvel em portugu\u00eas e em ingl\u00eas. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>Vou receber outros e-mails?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Junto com o guia, voc\u00ea recebe atualiza\u00e7\u00f5es regulat\u00f3rias ocasionais da Sobel, conforme o consentimento do formul\u00e1rio. Todo e-mail tem um link para cancelar a inscri\u00e7\u00e3o com um clique. <\/p><\/div><\/details>\n<\/div>\n<\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Is the guide really free?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. You only share your name, business email and company so we can send you the PDF.\"}},{\"@type\":\"Question\",\"name\":\"What changed in ISO 10993-1:2025 compared with 2018?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Biological evaluation is reorganized around ISO 14971 risk management, body-contact and duration categories change, reasonably foreseeable misuse enters the scope, and the single Table A.1 becomes four tables of biological effects. The guide covers all eight changes with the action expected for each.\"}},{\"@type\":\"Question\",\"name\":\"When was ISO 10993-1:2025 published, and what is the Brazilian edition?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"ISO 10993-1:2025, the sixth edition of the standard, was published in November 2025. In Brazil, ABNT published the new ABNT NBR ISO 10993-1 in September 2026, aligned with the 2025 edition, replacing the 2022 Brazilian edition that was based on the 2018 text.\"}},{\"@type\":\"Question\",\"name\":\"What should manufacturers do first to prepare?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Start with a documentation gap analysis: map your devices against the new contact categories, check that the Biological Evaluation Plan (BEP) and Report (BER) sit inside the ISO 14971 risk file, and justify every test you ran or did not run. The guide brings a five-step plan and a self-check.\"}},{\"@type\":\"Question\",\"name\":\"Do devices already on the market need new biocompatibility tests?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Not automatically. The standard does not require re-testing devices already on the market with an established, acceptable safety profile. A documented review of the existing data shows whether new data are needed or whether the BEP and BER only need to be updated. A gap analysis answers this for your specific device.\"}},{\"@type\":\"Question\",\"name\":\"Which markets does the guide cover?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The international standard and what it means in Brazil (ANVISA and the new ABNT NBR ISO 10993-1), the European Union (MDR) and the United States (FDA).\"}},{\"@type\":\"Question\",\"name\":\"Is it up to date, and is it available in Portuguese?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. Version 1.3 already covers the Brazilian ABNT NBR edition published in September 2026, and the guide is available in English and in Brazilian Portuguese.\"}},{\"@type\":\"Question\",\"name\":\"Will I receive other emails?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The guide comes with occasional regulatory updates from Sobel, as stated in the consent box. Every email has a one-click unsubscribe link.\"}}]}<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89ade2b elementor-widget elementor-widget-html\" data-id=\"89ade2b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<section style=\"background: #051B5A; padding: 72px 20px;\">\n  <div style=\"max-width: 900px; margin: 0 auto; display: flex; flex-direction: column; gap: 20px; align-items: center; text-align: center; font-family: 'Host Grotesk', sans-serif;\">\n    <p style=\"margin: 0; display: inline-flex; align-items: center; gap: 12px; font-family: 'Host Grotesk', sans-serif; font-weight: 600; font-size: 13px; letter-spacing: .16em; text-transform: uppercase; color: #F2B705;\"><span aria-hidden=\"true\" style=\"width: 9px; height: 9px; border-radius: 50%; background: #F2B705; display: inline-block;\"><\/span>Fique em dia com a atualiza\u00e7\u00e3o<\/p>\n    <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #FFFFFF;\">Baixe o guia gratuito da <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span><\/h2>\n    <p style=\"margin: 0; font-size: 18px; line-height: 1.6; max-width: 620px; color: #DCE1EE;\">A ISO 10993-1:2025 \u00e9 a edi\u00e7\u00e3o internacional atual e serve de refer\u00eancia para novas avalia\u00e7\u00f5es biol\u00f3gicas. A forma como ela \u00e9 aplicada varia de acordo com o mercado. <\/p>\n    <a href=\"#cta\" style=\"text-decoration: none; font-weight: 600; font-size: 17px; color: #FFFFFF; background: #F2B705; border-radius: 999px; padding: 16px 32px; margin-top: 8px;\">Baixe o guia gratuito<\/a>\n  <\/div>\n<\/section>\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","protected":false},"excerpt":{"rendered":"<p>E-book gratuito \u00b7 ISO 10993-1:2025 ISO 10993-1:2025: o que muda na Anvisa Guia pr\u00e1tico sobre o que mudou na avalia\u00e7\u00e3o biol\u00f3gica de dispositivos m\u00e9dicos e o que revisar no seu dossi\u00ea t\u00e9cnico na Anvisa. As 8 principais mudan\u00e7as em rela\u00e7\u00e3o \u00e0 edi\u00e7\u00e3o de 2018 O que muda na Anvisa, na ABNT NBR, na FDA e [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":15867,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-21758","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Guia ISO 10993-1:2025 gr\u00e1tis: o que muda na Anvisa | Sobel<\/title>\n<meta name=\"description\" content=\"E-book gratuito em portugu\u00eas: as 8 mudan\u00e7as da ISO 10993-1:2025, o que revisar no dossi\u00ea t\u00e9cnico da Anvisa e na ABNT NBR ISO 10993-1, e um plano em 5 etapas.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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