{"id":21785,"date":"2025-11-27T17:37:02","date_gmt":"2025-11-27T20:37:02","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/iso-10993-12025-guide\/"},"modified":"2026-11-12T05:20:27","modified_gmt":"2026-11-12T08:20:27","slug":"iso-10993-12025-guide","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/materiais\/iso-10993-12025-guide\/","title":{"rendered":"(ACTUAL) Gu\u00eda ISO 10993-1:2025 | E-book gratuito con novedades sobre biocompatibilidad"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"21785\" class=\"elementor elementor-21785 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\">Ya est\u00e1 aqu\u00ed la norma <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span>. \u00bfTienes listo tu expediente de biocompatibilidad? <\/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;\">Una gu\u00eda pr\u00e1ctica sobre los cambios que se han producido en la evaluaci\u00f3n biol\u00f3gica de los productos sanitarios y las medidas que tu equipo deber\u00eda priorizar ahora mismo.<\/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>Los 8 cambios clave respecto a la edici\u00f3n de 2018, antes y despu\u00e9s<\/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>Qu\u00e9 significa esto en Brasil (ABNT NBR), la UE y EE. UU.<\/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>Un plan de cinco pasos y una lista de comprobaci\u00f3n para tus dispositivos<\/span><\/li>\n      <\/ul>\n      <p style=\"margin: 0; font-size: 14px; color: #5A5F6A;\">Gu\u00eda ejecutiva de 8 p\u00e1ginas \u00b7 PDF \u00b7 Redactada por el equipo de Evidencia Cl\u00ednica y Seguridad de Productos de 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;\">El nuevo panorama de la evaluaci\u00f3n 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;\">Consigue la gu\u00eda gratis<\/p>\n    <p style=\"margin: 0; font-size: 14px; line-height: 1.45; color: #5A5F6A;\">Te enviamos el PDF directamente a tu bandeja de entrada.<\/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;Siguiente&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=\"Formulario de contacto - LP_EBOOK_ISO_ENG\" aria-label=\"Formulario de contacto - LP_EBOOK_ISO_ENG\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"21785\"\/>\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\tNombre 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=\"Tu nombre\" 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=\"Nombre de la 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\tCorreo electr\u00f3nico del trabajo\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=\"name@company.com\" 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\t\u00bfD\u00f3nde est\u00e1 tu dispositivo hoy?\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=\"\">Elige una opci\u00f3n<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"En fase de desarrollo\">En fase de desarrollo<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ya a la venta\">Ya a la venta<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Preparando una solicitud\">Preparando una solicitud<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Respondiendo a una autoridad o a un auditor\">Respondiendo a una autoridad o a un auditor<\/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\">Acepto la pol\u00edtica de privacidad y doy mi consentimiento para recibir la gu\u00eda y actualizaciones normativas ocasionales de 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\">Env\u00edame la gu\u00eda<\/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        $(\"form\").submit(function() {\r\n            var full_number = telefones[i].getNumber(intlTelInputUtils.numberFormat.E164);\r\n            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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;\">Contamos con la confianza de fabricantes de Brasil y del extranjero<\/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>Certificaci\u00f3n ISO 9001 en Brasil<\/span>\n      <span aria-hidden=\"true\" style=\"color: #F2B705;\">\u2022<\/span>\n      <span>Mejor consultor en normativa de productos sanitarios \u00b7 Am\u00e9rica Latina 2025<\/span>\n      <span aria-hidden=\"true\" style=\"color: #F2B705;\">\u2022<\/span>\n      <span>ANVISA \u00b7 FDA \u00b7 MDR\/IVDR de la 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>\u00bfQu\u00e9 cambia?<\/p>\n    <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">\u00bfQu\u00e9 cambia en la norma <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\">La norma ISO 10993-1:2025<\/span> es la sexta edici\u00f3n de la norma sobre la evaluaci\u00f3n biol\u00f3gica de los productos sanitarios. Reorganiza la evaluaci\u00f3n biol\u00f3gica en torno al proceso de gesti\u00f3n de riesgos <strong>de la norma ISO 14971<\/strong>, introduce nuevas <strong>categor\u00edas de contacto con el cuerpo<\/strong> y una forma m\u00e1s clara de contabilizar <strong>los d\u00edas de contacto<\/strong>, sustituye la \u00fanica tabla A.1 por cuatro tablas de efectos biol\u00f3gicos y refuerza el papel de <strong>la caracterizaci\u00f3n qu\u00edmica<\/strong>, <strong>la bioacumulaci\u00f3n<\/strong> y las alternativas a los ensayos con animales en el marco de <strong>las 3R<\/strong>. <\/p>\n    <p style=\"max-width: 760px; margin: 0; font-size: 18px; line-height: 1.65;\">En Brasil, la edici\u00f3n de 2025 ya se ha publicado con el t\u00edtulo <strong><span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span><\/strong>. <a href=\"https:\/\/sobelconsult.com\/es\/abnt-nbr-iso-10993-1-anvisa-informacion\/\" style=\"color: #051B5A; font-weight: 600;\">Descubre qu\u00e9 implica esto para las solicitudes a la ANVISA<\/a>.<\/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\">De un vistazo<\/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\">Edici\u00f3n<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\">Sexta, publicada en noviembre 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\">Sustituye a<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\"><span style=\"white-space:nowrap\">a la norma 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\">En 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>, septiembre de 2026<\/dd><\/div><div style=\"padding:14px 0\"><dt style=\"font-size:14px;color:#5A5F6A;margin:0 0 4px\">En la gu\u00eda<\/dt><dd style=\"margin:0;font-size:17px;font-weight:600;color:#051B5A\">8 cambios clave y un plan de cinco pasos<\/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>Qu\u00e9 hay dentro<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Todo lo que ha cambiado, en una gu\u00eda pr\u00e1ctica<\/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;\">La revisi\u00f3n de 2025 de un vistazo<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">M\u00e1s integrado, m\u00e1s basado en el riesgo y m\u00e1s orientado al ciclo de vida: qu\u00e9 significa eso en la pr\u00e1ctica.<\/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;\">La norma ISO 14971 y el uso indebido previsible<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">La evaluaci\u00f3n biol\u00f3gica se basa en el proceso de gesti\u00f3n de riesgos de la norma ISO 14971, incluyendo los usos indebidos razonablemente previsibles.<\/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;\">Categor\u00edas de contacto y exposici\u00f3n<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">Las nuevas categor\u00edas de contacto con el cuerpo y el tiempo total de exposici\u00f3n para los dispositivos con m\u00faltiples puntos de contacto.<\/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;\">Datos qu\u00edmicos y efectos biol\u00f3gicos<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">El papel de la caracterizaci\u00f3n qu\u00edmica y las cuatro tablas de efectos biol\u00f3gicos, seg\u00fan el tipo de contacto con el cuerpo.<\/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;\">Dispositivos antiguos y ciclo de vida<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">\u00bfQu\u00e9 dispositivos que ya est\u00e1n en el mercado hay que revisar, desde su desarrollo hasta el final de su 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 pasos para prepararte<\/h3><p style=\"margin: 0; font-size: 16px; line-height: 1.6;\">Desde definir el alcance y las categor\u00edas hasta establecer una rutina de revisi\u00f3n continua.<\/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>Un vistazo al interior<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">La tabla de \u00abantes y despu\u00e9s\u00bb que tu equipo va a usar de verdad<\/h2>\n      <p style=\"margin: 0; font-size: 17px; line-height: 1.6;\">Ocho temas, cada uno con lo que ha cambiado y lo que se espera que hagas. Aqu\u00ed tienes dos de ellos. <\/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;\">Consigue los 8 en la gu\u00eda<\/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;\">Lo que tienes que hacer<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; font-weight: 600; color: #051B5A;\">Integraci\u00f3n con la norma ISO 14971<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">Es obligatorio, pero se organiza en torno a los ex\u00e1menes.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">Se basa en el proceso de gesti\u00f3n de riesgos de la norma ISO 14971.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; background: #FDF0CE; color: #051B5A; font-weight: 500;\">Elabora el BEP y el BER sobre gesti\u00f3n de riesgos.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; font-weight: 600; color: #051B5A;\">Dispositivos que ya est\u00e1n en el mercado<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">Hacerse otra prueba ya no era obligatorio.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF;\">El mismo principio, pero con una revisi\u00f3n documentada de los datos existentes.<\/div>\n        <div style=\"padding: 16px 14px; border-top: 1px solid #E8E4DF; background: #FDF0CE; color: #051B5A; font-weight: 500;\">Comprueba si tu evaluaci\u00f3n sigue siendo 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 m\u00e1s en la gu\u00eda<\/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>A qui\u00e9n va dirigido<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Escrito para los equipos que se encargan del expediente<\/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 productos sanitarios que entran en contacto con el cuerpo, incluidos los productos dentales<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Equipos de I+D, Calidad y Asuntos Regulatorios<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Empresas que exportan a mercados muy regulados<\/div>\n      <div style=\"background: #FFFFFF; border-radius: 12px; padding: 22px; font-size: 17px; line-height: 1.5; color: #051B5A;\">Startups de tecnolog\u00eda sanitaria y tecnolog\u00eda m\u00e9dica<\/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>Revisi\u00f3n r\u00e1pida<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #FFFFFF;\">Tres preguntas antes de tu pr\u00f3xima auditor\u00eda<\/h2>\n      <p style=\"margin: 0; font-size: 18px; line-height: 1.6; color: #DDE2F0;\">Si respondes \u00abno\u00bb o \u00abno estoy seguro\u00bb a alguna de ellas, una breve charla con nuestro equipo puede ayudarte a planificar los pr\u00f3ximos pasos.<\/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;\">Habla con nuestro equipo<\/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;\">Consigue la gu\u00eda antes que nadie<\/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>\u00bfTu Plan de Evaluaci\u00f3n Biol\u00f3gica hace referencia a la edici\u00f3n 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>\u00bfEst\u00e1 documentada la evaluaci\u00f3n biol\u00f3gica en tu expediente de riesgos seg\u00fan la norma 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>\u00bfPuedes justificar cada prueba que has hecho y cada una que no has hecho?<\/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\">OPINIONES DE LOS CLIENTES<\/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\">Una referencia a la hora de tomar decisiones que impulsan el avance de los productos.<\/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\">\u00ab<\/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\">Soluciones r\u00e1pidas, centradas en tus 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>\u00abSobel nos ha ofrecido un servicio cercano y centrado en los objetivos, con soluciones r\u00e1pidas. Estamos deseando colaborar con ellos en futuros proyectos\u00bb.<\/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>Director general \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\">\u00ab<\/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\">Amplia experiencia, colaboraci\u00f3n de verdad<\/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>\u00abSobel Consult siempre me ha brindado una colaboraci\u00f3n proactiva y de apoyo, con un alto nivel de competencia en un amplio abanico de cuestiones normativas\u00bb.<\/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>Expertos en marco normativo y transformaci\u00f3n digital \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\">Una orientaci\u00f3n normativa clara<\/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>El camino y las prioridades adecuadas para tu producto.<\/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\">Asistencia r\u00e1pida y eficaz<\/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>Actuamos con rapidez para que los proyectos sigan adelante.<\/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\">Consejos pr\u00e1cticos<\/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>Consejos pr\u00e1cticos para tu pr\u00f3ximo paso.<\/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=\"Evaluaci\u00f3n biol\u00f3gica de un producto sanitario en un laboratorio\" 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>\u00bfQui\u00e9n lo escribi\u00f3?<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Escrito por el equipo que elabora estos archivos<\/h2>\n      <p style=\"margin: 0; font-size: 18px; line-height: 1.6;\">Los especialistas de Sobel en asuntos regulatorios y seguridad biol\u00f3gica preparan la documentaci\u00f3n de evaluaci\u00f3n biol\u00f3gica para presentarla ante la ANVISA, la FDA y los Organismos Notificados de la UE, y hacen un seguimiento de c\u00f3mo aplica cada autoridad la normativa.<\/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>C\u00f3mo te ayuda Sobel<\/p>\n      <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #051B5A;\">Cuando la gu\u00eda se\u00f1ala alguna laguna, la subsanamos contigo<\/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;\">Est\u00e1s aqu\u00ed<\/span>\n        <h3 style=\"margin: 0; font-family: 'Lora', serif; font-size: 24px; font-weight: 500; line-height: 1.2; color: #051B5A;\">Esta gu\u00eda<\/h3>\n        <p style=\"margin: 0; font-size: 16px; line-height: 1.6; color: #2B2E34;\">Entiende los 8 cambios, f\u00edjate en lo que hay que hacer con cada uno y revisa t\u00fa mismo tu archivo en cinco pasos.<\/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>Tabla de \u00abantes y despu\u00e9s\u00bb<\/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>La opini\u00f3n de Brasil, la UE y EE. UU.<\/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>Autocomprobaci\u00f3n en cinco pasos<\/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 de aqu\u00ed, Sobel puede ayudarte<\/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\u00e1lisis de deficiencias<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">Se ha comprobado que tu archivo actual cumple con la nueva estructura de la norma <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 y BER<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">El plan y el informe se han elaborado o actualizado de acuerdo con la norma ISO 14971 y los principios de las 3R.<\/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;\">Formaci\u00f3n t\u00e9cnica<\/h3><p style=\"margin: 0; font-size: 15px; line-height: 1.55; color: #DDE2F0;\">La nueva norma, los NAM y los enfoques basados en el riesgo para tus equipos.<\/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;\">\u00bfNo sabes por d\u00f3nde empezar? Lo normal es empezar por un an\u00e1lisis de deficiencias. <\/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;\">Habla con un especialista<\/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\">Preguntas frecuentes<\/p><h2>Preguntas sobre la <em>gu\u00eda<\/em> <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span> <\/h2><p class=\"sbf-lead\">Lo que suelen preguntar los fabricantes antes de la descarga, y qu\u00e9 es lo que la gu\u00eda s\u00ed y no sustituye.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Haz tu pregunta \u2192<\/a><\/div>\n<div class=\"sbf-list\">\n<details class=\"sbf-item\" open=\"\"><summary><span>\u00bfDe verdad es gratis la gu\u00eda?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>S\u00ed. Solo tienes que darnos tu nombre, tu correo electr\u00f3nico de trabajo y el nombre de tu empresa para que podamos enviarte el PDF. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>\u00bfQu\u00e9 ha cambiado en <span style=\"white-space:nowrap\">la norma ISO 10993-1:2025<\/span> respecto a la de 2018?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>La evaluaci\u00f3n biol\u00f3gica se ha reorganizado en torno a la gesti\u00f3n de riesgos de la norma ISO 14971; han cambiado las categor\u00edas de contacto con el cuerpo y de duraci\u00f3n; se ha incluido en el \u00e1mbito de aplicaci\u00f3n el uso indebido razonablemente previsible; y la \u00fanica tabla A.1 se ha dividido en cuatro tablas de efectos biol\u00f3gicos. La gu\u00eda aborda los ocho cambios y explica qu\u00e9 medidas hay que tomar en cada caso. <\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>\u00bfCu\u00e1ndo se public\u00f3 <span style=\"white-space:nowrap\">la norma ISO 10993-1:2025<\/span> y cu\u00e1l es la edici\u00f3n brasile\u00f1a?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>La norma <span style=\"white-space:nowrap\">ISO 10993-1:2025<\/span>, la sexta edici\u00f3n, se public\u00f3 en noviembre de 2025. En Brasil, la ABNT public\u00f3 la nueva norma <span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span> en septiembre de 2026, alineada con la edici\u00f3n de 2025, sustituyendo a la edici\u00f3n brasile\u00f1a de 2022, que se basaba en el texto de 2018. <\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>\u00bfQu\u00e9 es lo primero que deber\u00edan hacer los fabricantes para prepararse?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Empieza por un an\u00e1lisis de las lagunas en la documentaci\u00f3n: compara tus dispositivos con las nuevas categor\u00edas de contacto, comprueba que el Plan de Evaluaci\u00f3n Biol\u00f3gica (BEP) y el Informe de Evaluaci\u00f3n Biol\u00f3gica (BER) se encuentren dentro del expediente de riesgos seg\u00fan la norma ISO 14971, y justifica cada ensayo que hayas realizado o que no hayas realizado. La gu\u00eda incluye un plan de cinco pasos y una autoevaluaci\u00f3n. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>\u00bfLos dispositivos que ya est\u00e1n en el mercado necesitan nuevas pruebas de biocompatibilidad?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>No autom\u00e1ticamente. La norma no exige volver a someter a ensayo los dispositivos que ya est\u00e1n en el mercado y que cuentan con un perfil de seguridad consolidado y aceptable. Una revisi\u00f3n documentada de los datos existentes permite determinar si se necesitan nuevos datos o si solo hay que actualizar el BEP y el BER. Un an\u00e1lisis de deficiencias te da la respuesta para tu dispositivo concreto.   <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>\u00bfQu\u00e9 mercados abarca la gu\u00eda?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>La norma internacional y lo que significa en Brasil (ANVISA y la nueva <a href=\"https:\/\/sobelconsult.com\/es\/abnt-nbr-iso-10993-1-anvisa-informacion\/\"><span style=\"white-space:nowrap\">ABNT NBR ISO 10993-1<\/span><\/a>), la Uni\u00f3n Europea (MDR) y Estados Unidos (FDA).<\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>\u00bfEst\u00e1 actualizado y est\u00e1 disponible en portugu\u00e9s?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>S\u00ed. La versi\u00f3n 1.3 ya incluye la edici\u00f3n brasile\u00f1a de la norma ABNT NBR publicada en septiembre de 2026, y la gu\u00eda est\u00e1 disponible en ingl\u00e9s y en portugu\u00e9s brasile\u00f1o. <\/p><\/div><\/details>\n<details class=\"sbf-item\"><summary><span>\u00bfRecibir\u00e9 m\u00e1s correos electr\u00f3nicos?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>La gu\u00eda incluye actualizaciones normativas ocasionales de Sobel, tal y como se indica en el recuadro de consentimiento. Cada correo electr\u00f3nico tiene un enlace para darte de baja con un solo clic. <\/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>Prep\u00e1rate para la actualizaci\u00f3n<\/p>\n    <h2 style=\"margin: 0; font-family: 'Lora', serif; font-weight: 700; font-size: 40px; line-height: 1.15; color: #FFFFFF;\">Descarga la gu\u00eda gratuita sobre la norma <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;\">La norma ISO 10993-1:2025 es la edici\u00f3n internacional vigente y sirve de referencia para las nuevas evaluaciones biol\u00f3gicas. Su aplicaci\u00f3n var\u00eda seg\u00fan el 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;\">Consigue la gu\u00eda gratis<\/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 Ya est\u00e1 aqu\u00ed la norma ISO 10993-1:2025. \u00bfTienes listo tu expediente de biocompatibilidad? Una gu\u00eda pr\u00e1ctica sobre los cambios que se han producido en la evaluaci\u00f3n biol\u00f3gica de los productos sanitarios y las medidas que tu equipo deber\u00eda priorizar ahora mismo. Los 8 cambios clave respecto a la edici\u00f3n de [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":15866,"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-21785","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>ISO 10993-1:2025 Gu\u00eda: Libro electr\u00f3nico gratuito sobre biocompatibilidad | Sobel<\/title>\n<meta name=\"description\" content=\"Gu\u00eda gratuita sobre la norma ISO 10993-1:2025: los 8 cambios clave respecto a 2018, qu\u00e9 significan para la ANVISA, la UE y la FDA, y un plan de cinco pasos para tu expediente de biocompatibilidad.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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