{"id":46405,"date":"2026-10-27T13:35:39","date_gmt":"2026-10-27T16:35:39","guid":{"rendered":"https:\/\/sobelconsult.com\/?page_id=46405"},"modified":"2026-10-27T13:35:40","modified_gmt":"2026-10-27T16:35:40","slug":"evidencia-clinica-seguridad-producto","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/evidencia-clinica-seguridad-producto\/","title":{"rendered":"Evidencia Cl\u00ednica y Seguridad del Producto"},"content":{"rendered":"<style id=\"sobel-pl-css\">\/* Sobel service page model (Blueprint 26\/10\/2026) *\/\n.ss{overflow-x:clip;background:#FAF7F2;color:#2B2E34;font-family:'Host Grotesk',system-ui,sans-serif}\n.ss *{box-sizing:border-box}\n.ss-sec{padding:64px 0;scroll-margin-top:74px;background:#FAF7F2}\n.ss-white{background:#fff}\n.ss-in{width:100%;max-width:1264px;margin:0 auto;padding:0 32px}\n.ss-crumb{margin:0 0 24px;font-size:13px;line-height:18px;font-weight:500;color:#4F535B}\n.ss-crumb 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Producto<\/span><\/p><p class=\"ss-eye\">Evidencia Cl\u00ednica y Seguridad del Producto<\/p><h1 class=\"ss-h1\">Evidencia de seguridad planificada una vez, <span>aprovechada<\/span> en cada mercado.<\/h1><p class=\"ss-lead\">Evaluaci\u00f3n biol\u00f3gica, caracterizaci\u00f3n qu\u00edmica, toxicolog\u00eda y evaluaci\u00f3n cl\u00ednica construidas como una sola l\u00ednea de evidencia, alineada con la estrategia regulatoria desde el inicio.<\/p><div class=\"ss-btns\"><a class=\"ss-btn\" href=\"#footer-cta\">Reserve su evaluaci\u00f3n<\/a><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/\">Encuentre su ruta regulatoria \u2192<\/a><\/div><ul class=\"ss-seals\"><li><i>\ud83c\udfc6<\/i>Top Medical Device Regulatory Consultant \u00b7 LatAm 2025<\/li><li><i>\u2713<\/i>ISO 9001 certificada en Brasil<\/li><li><i>\ud83c\udf10<\/i>Atenci\u00f3n en PT \u00b7 EN \u00b7 DE<\/li><\/ul><\/div><div class=\"ss-hero-p\"><img fetchpriority=\"high\" width=\"800\" height=\"645\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-1024x825.jpg\" class=\"ss-photo\" alt=\"Cient\u00edfico revisando un informe de evaluaci\u00f3n biol\u00f3gica junto a muestras de productos sanitarios\" loading=\"eager\" fetchpriority=\"high\" decoding=\"async\" data-no-lazy=\"1\" sizes=\"(max-width: 1024px) 100vw, 600px\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-1024x825.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-300x242.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-768x619.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation-1536x1237.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-biological-evaluation.jpg 1600w\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-who\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">\u00bfEs para usted?<\/p><h2 class=\"ss-h2\">Para qui\u00e9n hacemos esto<\/h2><\/div><div class=\"ss-g4\"><div class=\"ss-card\"><b>Producto nuevo, sin plan<\/b><span>Necesita decidir qu\u00e9 ensayos hacer antes de gastar en laboratorio.<\/span><\/div><div class=\"ss-card\"><b>Expediente anterior a 2025<\/b><span>Su evaluaci\u00f3n biol\u00f3gica necesita revisarse frente a la ISO 10993-1:2025.<\/span><\/div><div class=\"ss-card\"><b>Requerimiento de la autoridad<\/b><span>La autoridad cuestion\u00f3 la biocompatibilidad o la evidencia cl\u00ednica.<\/span><\/div><div class=\"ss-card\"><b>Nuevo mercado<\/b><span>Quiere aprovechar informes existentes en otro mercado.<\/span><\/div><\/div><\/div><\/section><section class=\"ss-sec pl-numsec\" id=\"pl-numbers\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">En n\u00fameros<\/p><h2 class=\"ss-h2\">Lo que muestran los datos<\/h2><\/div><div class=\"pl-nums\"><div class=\"pl-num\"><b>39 %<\/b><strong>de las solicitudes MDR rechazadas<\/strong><span>se rechazaron por estar incompletas, el motivo m\u00e1s frecuente en la encuesta de la Comisi\u00f3n Europea a los organismos notificados.<\/span><\/div><div class=\"pl-num\"><b>13 a 18<\/b><strong>meses es el plazo m\u00e1s com\u00fan hasta un nuevo certificado MDR<\/strong><span>para nuevos certificados emitidos en 2025 (48 % de los casos). Un expediente completo desde el inicio pesa en ese tiempo.<\/span><\/div><div class=\"pl-num\"><b>6.\u00aa<\/b><strong>edici\u00f3n de la ISO 10993-1, publicada en 2025<\/strong><span>La nueva edici\u00f3n integra la evaluaci\u00f3n biol\u00f3gica con la gesti\u00f3n de riesgos de la ISO 14971.<\/span><\/div><\/div><p class=\"pl-src\">Fuentes: Comisi\u00f3n Europea, encuesta a organismos notificados (datos hasta febrero de 2025); Team-NB, encuesta a organismos notificados europeos, datos de 2025; ISO 10993-1:2025.<\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-chain\"><div class=\"ss-in\"><div class=\"ss-head\"><p class=\"ss-eye\">La cadena de la evidencia<\/p><h2 class=\"ss-h2\">Cada etapa alimenta la siguiente<\/h2><p class=\"ss-sub\">Planificar la secuencia evita ensayos repetidos e informes que no dialogan entre s\u00ed.<\/p><\/div><div class=\"pl-seg\" role=\"group\"><button type=\"button\" class=\"pl-sb on\" data-pl-seg=\"md\" aria-pressed=\"true\">Productos sanitarios<\/button><button type=\"button\" class=\"pl-sb\" data-pl-seg=\"cos\" aria-pressed=\"false\">Cosm\u00e9ticos<\/button><\/div><div class=\"pl-chainbox\" data-pl-segbox=\"md\" data-pl-tabs><div class=\"pl-steps\" role=\"tablist\" style=\"--n:4\"><button type=\"button\" role=\"tab\" class=\"pl-st on\" aria-selected=\"true\" data-pl-t=\"biological-evaluation\"><i>1<\/i><b>Evaluaci\u00f3n biol\u00f3gica<\/b><small>ISO 10993-1:2025<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"chemical-characterization\"><i>2<\/i><b>Caracterizaci\u00f3n qu\u00edmica<\/b><small>ISO 10993-18<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"toxicological-risk-assessment\"><i>3<\/i><b>Evaluaci\u00f3n del riesgo toxicol\u00f3gico<\/b><small>ISO 10993-17<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"clinical-evaluation\"><i>4<\/i><b>Evaluaci\u00f3n cl\u00ednica<\/b><small>MDR de la UE \u00b7 ANVISA \u00b7 FDA<\/small><\/button><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"biological-evaluation\"><span class=\"pl-anchor\" id=\"biological-evaluation\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Para productos en contacto con el cuerpo, como parte del expediente t\u00e9cnico.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Plan de evaluaci\u00f3n biol\u00f3gica (BEP)<\/li><li>Informe de evaluaci\u00f3n biol\u00f3gica (BER)<\/li><li>An\u00e1lisis de brechas frente a la ISO 10993-1:2025<\/li><li>Estrategia de ensayos y coordinaci\u00f3n con laboratorios<\/li><\/ul><\/div><\/div><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"chemical-characterization\" hidden><span class=\"pl-anchor\" id=\"chemical-characterization\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Cuando es necesario conocer lo que el material puede liberar, como extra\u00edbles y lixiviables.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Estrategia de caracterizaci\u00f3n qu\u00edmica<\/li><li>Plan de extra\u00edbles y lixiviables<\/li><li>Interpretaci\u00f3n de los resultados del laboratorio<\/li><\/ul><\/div><\/div><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"toxicological-risk-assessment\" hidden><span class=\"pl-anchor\" id=\"toxicological-risk-assessment\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Cuando los datos qu\u00edmicos deben evaluarse en cuanto al riesgo para el paciente.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Informe de evaluaci\u00f3n del riesgo toxicol\u00f3gico<\/li><li>Margen de seguridad por sustancia<\/li><li>Justificaci\u00f3n para omitir ensayos, cuando corresponda<\/li><\/ul><\/div><\/div><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"clinical-evaluation\" hidden><span class=\"pl-anchor\" id=\"clinical-evaluation\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Para demostrar seguridad y desempe\u00f1o con datos cl\u00ednicos, seg\u00fan la clase y el mercado.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/evaluacion-clinica-para-registro-anvisa\/\">Evaluaci\u00f3n cl\u00ednica \u00b7 Brasil \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Plan e informe de evaluaci\u00f3n cl\u00ednica<\/li><li>Revisi\u00f3n sistem\u00e1tica de la literatura<\/li><li>An\u00e1lisis de equivalencia, cuando corresponda<\/li><li>Base para el seguimiento poscomercializaci\u00f3n<\/li><\/ul><\/div><\/div><\/div><\/div><div class=\"pl-chainbox\" data-pl-segbox=\"cos\" hidden data-pl-tabs><div class=\"pl-steps\" role=\"tablist\" style=\"--n:3\"><button type=\"button\" role=\"tab\" class=\"pl-st on\" aria-selected=\"true\" data-pl-t=\"formula-review\"><i>1<\/i><b>F\u00f3rmula e ingredientes<\/b><small>Listas de sustancias de cada mercado<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"safety-assessment\"><i>2<\/i><b>Evaluaci\u00f3n de seguridad<\/b><small>CPSR (UE y Reino Unido) \u00b7 MoCRA (EE. UU.)<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"cosmetovigilance\"><i>3<\/i><b>Poscomercializaci\u00f3n<\/b><small>Cosmetovigilancia<\/small><\/button><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"formula-review\"><span class=\"pl-anchor\" id=\"formula-review\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Antes de notificar o registrar, para revisar ingredientes y concentraciones en cada mercado.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/es\/cumplimiento-cosmetico-de-anvisa-en-brasil\/\">Cosm\u00e9ticos \u00b7 Brasil \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Revisi\u00f3n de la f\u00f3rmula frente a las listas de cada mercado<\/li><li>Puntos de atenci\u00f3n por ingrediente<\/li><li>Apoyo en el etiquetado<\/li><\/ul><\/div><\/div><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"safety-assessment\" hidden><span class=\"pl-anchor\" id=\"safety-assessment\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Para demostrar la seguridad del producto antes de comercializarlo.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Apoyo en la evaluaci\u00f3n de seguridad<\/li><li>Coordinaci\u00f3n del informe de seguridad con un evaluador calificado<\/li><li>Datos de seguridad para la notificaci\u00f3n<\/li><\/ul><\/div><\/div><\/div><div class=\"pl-panel pl-cpanel\" role=\"tabpanel\" data-pl-p=\"cosmetovigilance\" hidden><span class=\"pl-anchor\" id=\"cosmetovigilance\"><\/span><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Cu\u00e1ndo suele pedirse<\/p><p class=\"pl-d\">Despu\u00e9s del lanzamiento, para seguir efectos indeseables y cambios de f\u00f3rmula.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Rutina de cosmetovigilancia<\/li><li>Evaluaci\u00f3n de cambios de f\u00f3rmula<\/li><li>Apoyo en las comunicaciones con la autoridad<\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"ss-sec\" id=\"pl-markets\"><div class=\"ss-in\"><div class=\"ss-head\"><p class=\"ss-eye\">En cada mercado<\/p><h2 class=\"ss-h2\">Lo que cada autoridad suele mirar<\/h2><p class=\"ss-sub\">La base cient\u00edfica es la misma. Lo que cambia es el formato y el nivel de evidencia que pide cada mercado.<\/p><\/div><div class=\"pl-mk\" data-pl-tabs><div class=\"pl-mtabs\" role=\"tablist\"><button type=\"button\" role=\"tab\" class=\"pl-mt on\" aria-selected=\"true\" data-pl-t=\"mk-br\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#229E45\"\/><path d=\"M3 10 15 2 27 10 15 18Z\" fill=\"#F8E509\"\/><circle cx=\"15\" cy=\"10\" r=\"4.5\" fill=\"#2B49A3\"\/><\/svg><span>Brasil<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-eu\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#003399\"\/><g fill=\"#FFCC00\"><circle cx=\"21.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"15\" cy=\"16.5\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"8.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"6.75\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"15\" cy=\"3.5\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"6.75\" r=\"1.2\"\/><\/g><\/svg><span>Uni\u00f3n Europea<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-uk\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#012169\"\/><path d=\"M0 0h4l26 17v3h-4L0 3Z M30 0v3L4 20H0v-3L26 0Z\" fill=\"#fff\"\/><path d=\"M11 0h8v20h-8Z M0 6h30v8H0Z\" fill=\"#fff\"\/><path d=\"M12.8 0h4.4v20h-4.4Z M0 7.8h30v4.4H0Z\" fill=\"#C8102E\"\/><\/svg><span>Reino Unido<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-us\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect y=\"0\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"2.86\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"5.71\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"8.57\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"11.43\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"14.29\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"17.14\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect width=\"13\" height=\"11.43\" fill=\"#3C3B6E\"\/><\/svg><span>EE. UU.<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-ca\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#fff\"\/><rect width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><rect x=\"22.5\" width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><path d=\"M15 4l2 4 3-1-2 5h-2v4h-2v-4h-2l-2-5 3 1Z\" fill=\"#D80621\"\/><\/svg><span>Canad\u00e1<\/span><\/button><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-br\"><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#229E45\"\/><path d=\"M3 10 15 2 27 10 15 18Z\" fill=\"#F8E509\"\/><circle cx=\"15\" cy=\"10\" r=\"4.5\" fill=\"#2B49A3\"\/><\/svg>Brasil \u00b7 ANVISA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Productos sanitarios<\/p><p>ANVISA suele pedir la evaluaci\u00f3n biol\u00f3gica en el expediente t\u00e9cnico y evidencia cl\u00ednica proporcional a la clase y al riesgo del producto.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Para cosm\u00e9ticos, la empresa responsable mantiene los datos de seguridad del producto, y la cosmetovigilancia acompa\u00f1a la poscomercializaci\u00f3n.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-eu\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#003399\"\/><g fill=\"#FFCC00\"><circle cx=\"21.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"15\" cy=\"16.5\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"8.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"6.75\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"15\" cy=\"3.5\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"6.75\" r=\"1.2\"\/><\/g><\/svg>Uni\u00f3n Europea \u00b7 MDR de la UE<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Productos sanitarios<\/p><p>El MDR exige evaluaci\u00f3n cl\u00ednica para todos los productos, actualizada a lo largo del ciclo de vida. La biocompatibilidad suele evaluarse con la serie ISO 10993.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Cada cosm\u00e9tico necesita un informe de seguridad (CPSR) firmado por un evaluador calificado, guardado en el expediente de informaci\u00f3n del producto.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-uk\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#012169\"\/><path d=\"M0 0h4l26 17v3h-4L0 3Z M30 0v3L4 20H0v-3L26 0Z\" fill=\"#fff\"\/><path d=\"M11 0h8v20h-8Z M0 6h30v8H0Z\" fill=\"#fff\"\/><path d=\"M12.8 0h4.4v20h-4.4Z M0 7.8h30v4.4H0Z\" fill=\"#C8102E\"\/><\/svg>Reino Unido \u00b7 MHRA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Productos sanitarios<\/p><p>El Reino Unido sigue una l\u00f3gica similar: evaluaci\u00f3n biol\u00f3gica con la serie ISO 10993 y evidencia cl\u00ednica seg\u00fan la clase.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Las reglas del Reino Unido tambi\u00e9n piden un informe de seguridad del producto cosm\u00e9tico.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-us\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect y=\"0\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"2.86\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"5.71\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"8.57\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"11.43\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"14.29\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"17.14\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect width=\"13\" height=\"11.43\" fill=\"#3C3B6E\"\/><\/svg>EE. UU. \u00b7 FDA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Productos sanitarios<\/p><p>La FDA tiene una gu\u00eda propia sobre el uso de la ISO 10993-1, y la necesidad de datos cl\u00ednicos depende de la v\u00eda: 510(k), De Novo o PMA.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>MoCRA exige que el responsable mantenga la sustentaci\u00f3n de la seguridad de cada cosm\u00e9tico.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-ca\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#fff\"\/><rect width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><rect x=\"22.5\" width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><path d=\"M15 4l2 4 3-1-2 5h-2v4h-2v-4h-2l-2-5 3 1Z\" fill=\"#D80621\"\/><\/svg>Canad\u00e1 \u00b7 Health Canada<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Productos sanitarios<\/p><p>Health Canada pide evidencia de seguridad y eficacia proporcional a la clase, y la serie ISO 10993 suele ser la referencia para biocompatibilidad.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>El fabricante responde por la seguridad del cosm\u00e9tico y notifica el producto a Health Canada.<\/p><\/div><\/div><\/div><p class=\"pl-note\">El requisito exacto depende del producto, de la clase y de la v\u00eda elegida. Lo confirmamos en su evaluaci\u00f3n.<\/p><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-team\"><div class=\"ss-in pl-team\"><div><p class=\"ss-eye\">Dos equipos, un solo expediente<\/p><h2 class=\"ss-h2\">Regulatorio y Calidad \u00d7 Evidencia Cl\u00ednica y Seguridad del Producto<\/h2><p class=\"ss-sub\">La estrategia regulatoria define lo que cada mercado va a pedir. La evidencia de seguridad muestra que el producto cumple. Cuando los dos equipos planifican juntos, cada ensayo y cada informe nacen con un destino claro.<\/p><\/div><ol class=\"pl-meet\"><li><i>1<\/i><span>Clasificaci\u00f3n y uso previsto<\/span><\/li><li><i>2<\/i><span>Plan de evidencia por mercado<\/span><\/li><li><i>3<\/i><span>Elecci\u00f3n de ensayos y laboratorios<\/span><\/li><li><i>4<\/i><span>Respuestas a las autoridades<\/span><\/li><\/ol><\/div><\/section><section class=\"ss-sec\" id=\"pl-how\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">C\u00f3mo trabajamos<\/p><h2 class=\"ss-h2\">De la revisi\u00f3n del material al informe, en cinco etapas<\/h2><p class=\"ss-sub\">Usted sigue cada etapa en el Sobel Client Workspace.<\/p><\/div><ol class=\"ss-steps pl-how\"><li><span class=\"ss-num\">1<\/span><b>Revisi\u00f3n del producto y de los materiales<\/b><span>Uso previsto, contacto con el cuerpo, materiales y lo que ya existe.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">2<\/span><b>Plan de evidencia<\/b><span>Qu\u00e9 se puede aprovechar y qu\u00e9 hay que complementar.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">3<\/span><b>Ensayos con laboratorios calificados<\/b><span>Coordinamos el laboratorio que usted elija o que le recomendemos.<\/span><em class=\"pl-who\">Sobel y laboratorio<\/em><\/li><li><span class=\"ss-num\">4<\/span><b>Informes<\/b><span>Informes en el formato que cada autoridad suele pedir.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">5<\/span><b>Apoyo en las preguntas de la autoridad<\/b><span>Respuestas t\u00e9cnicas a los requerimientos, junto con su equipo.<\/span><em class=\"pl-who\">Sobel y usted<\/em><\/li><\/ol><p class=\"ss-c ss-after\"><a class=\"ss-btn\" href=\"#footer-cta\">Hable con un especialista<\/a><\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-cross\"><div class=\"ss-in pl-crossg\"><div class=\"pl-crossp\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"598\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team-1024x765.jpg\" class=\"ss-photo2\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team-1024x765.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team-300x224.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team-768x574.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team-1536x1147.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-evidence-team.jpg 1600w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><div><p class=\"ss-eye\">Relacionados<\/p><h2 class=\"ss-h2\">Siga explorando<\/h2><div class=\"pl-clist\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/es\/regulatorio-calidad\/\"><b>Regulatorio y Calidad<\/b><span>Registro, sistemas de calidad, riesgos y auditor\u00edas.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-brazil\/evaluacion-clinica-para-registro-anvisa\/\"><b>Evaluaci\u00f3n cl\u00ednica \u00b7 Brasil<\/b><span>Evidencia cl\u00ednica para el registro en ANVISA.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/\"><b>Sobel Route<\/b><span>Vea lo que hacemos en cada mercado y arme su ruta.<\/span><em>\u2192<\/em><\/a><\/div><a class=\"pl-free\" href=\"https:\/\/sobelconsult.com\/es\/materiais\/iso-10993-12025-guide\/\"><small>Material gratuito<\/small><b>E-book ISO 10993-1:2025<\/b><span>Qu\u00e9 cambi\u00f3 en la nueva edici\u00f3n y c\u00f3mo revisar su evaluaci\u00f3n biol\u00f3gica.<\/span><em>Descargar \u2192<\/em><\/a><\/div><\/div><\/section><div class=\"ss-why\">\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46194\" class=\"elementor elementor-46194 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" 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-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" 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\">\u00bfPor qu\u00e9 Sobel?<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" 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\">La normativa como una <span class=\"sbw-gold\">decisi\u00f3n<\/span> de negocio <span class=\"sbw-gold\">,<\/span> no como una lista de tareas.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" 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>En cada proyecto colaboran cuatro disciplinas, todas dentro del mismo equipo, desde la primera decisi\u00f3n hasta la fase posterior a la comercializaci\u00f3n.<\/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-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" 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\">Estrategia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" 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>Lo primero es decidir la clasificaci\u00f3n y el orden de salida al mercado. Elegir la categor\u00eda adecuada desde el primer d\u00eda evita tener que volver a hacerlo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" 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\">Ciencia propia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" 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>Evaluaci\u00f3n biol\u00f3gica, cl\u00ednica y toxicol\u00f3gica realizada por nuestro propio equipo de Evidencia Cl\u00ednica y Seguridad de los Productos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" 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\">Normativa, cinco mercados<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" 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>La ANVISA, la FDA, el MDR y el IVDR de la UE, la MHRA y Health Canada trabajaron de forma coordinada.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" 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\">Tecnolog\u00eda<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" 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>Un equipo t\u00e9cnico especializado se encarga de crear los flujos de trabajo que garantizan la trazabilidad y el cumplimiento de los plazos en cada proyecto.<\/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-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" 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-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" 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>\u00abSabemos c\u00f3mo piensan los auditores, porque hemos sido uno de ellos\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-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" 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=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44767\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\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-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" 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\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" 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\">Fundador y director general<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" 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<ul><li>Ingeniero mec\u00e1nico, formado en Alemania<\/li><li>Antiguo auditor de BSI (Organismo Notificado)<\/li><li>Experiencia en el sector en Sirona y Dentsply<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/home\/quienes-somos\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Conoce al equipo \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" 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>.sbw-gold{color:#F2B705}.sbw-eye .elementor-heading-title{display:flex;align-items:center;gap:10px}.sbw-eye .elementor-heading-title:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705;flex:none}.sbw-list ul{margin:0;padding-left:18px}.sbw-list li{margin:4px 0}.sbw-list li::marker{color:#F2B705}@media(max-width:1024px){.sbw-native > .sbw-l, .sbw-native > .sbw-card{width:100%!important}}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div><section class=\"ss-sec\" id=\"pl-faq\"><div class=\"ss-in ss-faqg\"><div><p class=\"ss-eye\">Preguntas y respuestas<\/p><h2 class=\"ss-h2\">Preguntas frecuentes<\/h2><p class=\"ss-rules\"><b>Normas citadas en esta p\u00e1gina:<\/b> ISO 10993-1:2025 \u00b7 ISO 10993-17 \u00b7 ISO 10993-18 \u00b7 ISO 14971:2019 \u00b7 MDR de la UE \u00b7 Reglamento (CE) 1223\/2009 \u00b7 MoCRA<\/p><\/div><div class=\"ss-faq\"><details open><summary>\u00bfSobel realiza los ensayos de laboratorio?<\/summary><p>No. Los ensayos los realizan laboratorios calificados, que usted elige o que le recomendamos. Sobel planifica la estrategia, coordina el laboratorio e interpreta los resultados.<\/p><\/details><details><summary>\u00bfDebo repetir ensayos por la ISO 10993-1:2025?<\/summary><p>No siempre. En general, un an\u00e1lisis de brechas muestra qu\u00e9 se puede aprovechar y qu\u00e9 hay que complementar. Lo confirmamos en su evaluaci\u00f3n.<\/p><\/details><details><summary>\u00bfUn mismo informe puede servir a varios mercados?<\/summary><p>Suele ser posible partir de una base com\u00fan y adaptarla al formato y al nivel de evidencia que pide cada autoridad.<\/p><\/details><details><summary>\u00bfRealizan evaluaci\u00f3n cl\u00ednica?<\/summary><p>S\u00ed, para productos sanitarios, con revisi\u00f3n de la literatura y an\u00e1lisis de equivalencia cuando corresponda, alineada con lo que cada mercado suele pedir.<\/p><\/details><details><summary>\u00bfEval\u00faan la seguridad de cosm\u00e9ticos?<\/summary><p>Apoyamos la evaluaci\u00f3n de seguridad y coordinamos el informe con un evaluador calificado, seg\u00fan las reglas de cada mercado.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"\\u00bfSobel realiza los ensayos de laboratorio?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. Los ensayos los realizan laboratorios calificados, que usted elige o que le recomendamos. 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