{"id":46403,"date":"2026-10-27T13:35:37","date_gmt":"2026-10-27T16:35:37","guid":{"rendered":"https:\/\/sobelconsult.com\/?page_id=46403"},"modified":"2026-10-27T13:35:40","modified_gmt":"2026-10-27T16:35:40","slug":"regulatorio-calidad","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/regulatorio-calidad\/","title":{"rendered":"Regulatorio y Calidad"},"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 a{color:#4F535B!important;text-decoration:none!important;font-weight:500;font-size:13px}.ss-crumb 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(max-width:1024px){.pl-crossg{grid-template-columns:1fr;gap:28px}}\n#pl-chain .ss-head{margin-bottom:26px}\n.pl-cpanel{padding:24px 28px}\n.pl-seg{margin-bottom:18px}\n@media (min-width:1025px) and (max-height:840px){.pl-hint{display:none}.pl-need .pl-panel{padding:20px 22px}}\n<\/style><div class=\"ss pl\" data-p=\"rq\"><section class=\"ss-sec ss-hero\"><div class=\"ss-in ss-hero-g\"><div class=\"ss-hero-t\"><p class=\"ss-crumb\"><a href=\"https:\/\/sobelconsult.com\/es\/\">Inicio<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/\">Soluciones<\/a> \u203a <span class=\"cur\">Regulatorio y Calidad<\/span><\/p><p class=\"ss-eye\">Regulatorio y Calidad<\/p><h1 class=\"ss-h1\">Acceso al mercado y un sistema de calidad que <span>se sostiene<\/span> en la auditor\u00eda.<\/h1><p class=\"ss-lead\">Registro, sistemas de calidad, gesti\u00f3n de riesgos y auditor\u00edas planificados juntos, para que el trabajo hecho para un mercado sirva de base para el siguiente.<\/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-regulatory-quality-audit-1024x825.jpg\" class=\"ss-photo\" alt=\"Especialista de calidad revisando documentaci\u00f3n de un producto sanitario en una planta\" 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-regulatory-quality-audit-1024x825.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-300x242.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-768x619.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-1536x1237.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit.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>Primer registro<\/b><span>Necesita clasificaci\u00f3n, estrategia y un sistema de calidad que la autoridad acepte.<\/span><\/div><div class=\"ss-card\"><b>Sistema por montar o adecuar<\/b><span>Su sistema a\u00fan no cubre ISO 13485, MDSAP, BPF de ANVISA o el QMSR de la FDA.<\/span><\/div><div class=\"ss-card\"><b>Auditor\u00eda o inspecci\u00f3n cercana<\/b><span>Quiere probar el sistema antes de quien va a certificar o inspeccionar.<\/span><\/div><div class=\"ss-card\"><b>Proveedores por calificar<\/b><span>Necesita auditar proveedores en Brasil o en el exterior.<\/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\">D\u00f3nde se exige la calidad<\/h2><\/div><div class=\"pl-nums\"><div class=\"pl-num\"><b>31.215<\/b><strong>certificados ISO 13485 en el mundo<\/strong><span>en 43.957 sitios certificados. Es la base m\u00e1s com\u00fan para demostrar un sistema de calidad en productos sanitarios.<\/span><\/div><div class=\"pl-num\"><b>31.426<\/b><strong>auditor\u00edas MDSAP realizadas<\/strong><span>de 2018 a mayo de 2025, en 82 pa\u00edses. Una auditor\u00eda la usan las cinco autoridades del programa, entre ellas ANVISA, la FDA y Health Canada.<\/span><\/div><div class=\"pl-num\"><b>1.\u00ba<\/b><strong>CAPA es el punto que m\u00e1s se\u00f1ala la FDA<\/strong><span>279 de las 2.660 observaciones en inspecciones de productos sanitarios en el a\u00f1o fiscal 2025. Quejas (211) vienen despu\u00e9s.<\/span><\/div><\/div><p class=\"pl-src\">Fuentes: ISO Survey 2024 (ISO); MDSAP Today, IMDRF, 2026; FDA, Inspection Observations, a\u00f1o fiscal 2025.<\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-need\"><div class=\"ss-in\"><div class=\"ss-head\"><p class=\"ss-eye\">\u00bfQu\u00e9 necesita?<\/p><h2 class=\"ss-h2\">Elija un tema y vea lo que suele implicar<\/h2><\/div><div class=\"pl-need\" data-pl-tabs><div class=\"pl-list\" role=\"tablist\" aria-label=\"\u00bfQu\u00e9 necesita?\"><button type=\"button\" role=\"tab\" class=\"pl-it on\" aria-selected=\"true\" aria-controls=\"pl-p-registration\" data-pl-t=\"registration\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M6 3h9l4 4v14H6z\"\/><path d=\"M14 3v5h5\"\/><path d=\"M9 14l2 2 4-4\"\/><\/svg><\/span><span><b>Registro y acceso al mercado<\/b><small>ANVISA, UE, Reino Unido, FDA, Health Canada<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-quality-systems\" data-pl-t=\"quality-systems\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3l7 3v6c0 4.5-3 7.5-7 9-4-1.5-7-4.5-7-9V6z\"\/><path d=\"M9 12l2 2 4-4\"\/><\/svg><\/span><span><b>Sistemas de calidad<\/b><small>ISO 13485, MDSAP, BPF de ANVISA, QMSR<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-risk-management\" data-pl-t=\"risk-management\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3 2.5 20h19z\"\/><path d=\"M12 10v4\"\/><path d=\"M12 17h.01\"\/><\/svg><\/span><span><b>Gesti\u00f3n de riesgos<\/b><small>ISO 14971<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-audits\" data-pl-t=\"audits\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><rect x=\"6\" y=\"4\" width=\"12\" height=\"17\" rx=\"2\"\/><path d=\"M9 3h6v3H9z\"\/><path d=\"M9 13l2 2 4-4\"\/><\/svg><\/span><span><b>Auditor\u00edas<\/b><small>Internas, de proveedores y simuladas<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-training\" data-pl-t=\"training\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M2 9l10-5 10 5-10 5z\"\/><path d=\"M6 11v5c0 2 12 2 12 0v-5\"\/><path d=\"M22 9v6\"\/><\/svg><\/span><span><b>Capacitaciones<\/b><small>In company, para equipos regulatorios y de calidad<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><\/div><div class=\"pl-panels\"><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-registration\" data-pl-p=\"registration\"><span class=\"pl-anchor\" id=\"registration\"><\/span><h3 class=\"ss-h3\">Registro y acceso al mercado<\/h3><p class=\"pl-d\">Clasificaci\u00f3n, estrategia de mercados y expediente en el formato de cada autoridad. Para ver la ruta de su producto, mercado por mercado, use la herramienta Sobel Route.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Clasificaci\u00f3n y v\u00eda regulatoria<\/li><li>Secuencia de mercados que aprovecha lo que usted ya tiene<\/li><li>Expediente t\u00e9cnico en el formato de cada autoridad<\/li><li>Seguimiento de los requerimientos<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referencias<\/p><p class=\"pl-chips\"><span>RDC 751\/2022<\/span><span>MDR de la UE<\/span><span>FDA<\/span><span>Health Canada<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/\">Encuentre su ruta regulatoria \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-quality-systems\" data-pl-p=\"quality-systems\" hidden><span class=\"pl-anchor\" id=\"quality-systems\"><\/span><h3 class=\"ss-h3\">Sistemas de calidad<\/h3><p class=\"pl-d\">Implementaci\u00f3n, adecuaci\u00f3n o integraci\u00f3n del sistema de calidad, dise\u00f1ado para atender a m\u00e1s de un mercado con la misma base.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Diagn\u00f3stico del sistema actual<\/li><li>Manual, procedimientos y registros<\/li><li>Integraci\u00f3n con la gesti\u00f3n de riesgos<\/li><li>Preparaci\u00f3n para certificaci\u00f3n o inspecci\u00f3n<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referencias<\/p><p class=\"pl-chips\"><span>ISO 13485:2016<\/span><span>MDSAP<\/span><span>RDC 665\/2022<\/span><span>FDA QMSR<\/span><span>ISO 22716<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-risk-management\" data-pl-p=\"risk-management\" hidden><span class=\"pl-anchor\" id=\"risk-management\"><\/span><h3 class=\"ss-h3\">Gesti\u00f3n de riesgos<\/h3><p class=\"pl-d\">Un proceso de gesti\u00f3n de riesgos que acompa\u00f1a al producto del dise\u00f1o al poscomercializaci\u00f3n y dialoga con el resto del expediente t\u00e9cnico.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Plan e informe de gesti\u00f3n de riesgos<\/li><li>An\u00e1lisis de riesgos, por ejemplo FMEA<\/li><li>V\u00ednculo con usabilidad, biocompatibilidad y poscomercializaci\u00f3n<\/li><li>Revisi\u00f3n de expedientes existentes<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referencias<\/p><p class=\"pl-chips\"><span>ISO 14971:2019<\/span><span>ISO\/TR 24971<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-audits\" data-pl-p=\"audits\" hidden><span class=\"pl-anchor\" id=\"audits\"><\/span><h3 class=\"ss-h3\">Auditor\u00edas<\/h3><p class=\"pl-d\">Auditor\u00edas realizadas por quien conoce el otro lado de la mesa. Presenciales, remotas o h\u00edbridas, para productos sanitarios y cosm\u00e9ticos.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Auditor\u00eda interna del sistema de calidad<\/li><li>Calificaci\u00f3n y auditor\u00eda de proveedores<\/li><li>Auditor\u00eda simulada antes de certificaci\u00f3n o inspecci\u00f3n<\/li><li>Informe con no conformidades y prioridades<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referencias<\/p><p class=\"pl-chips\"><span>ISO 19011<\/span><span>ISO 13485<\/span><span>MDSAP<\/span><span>RDC 665\/2022<\/span><span>ISO 22716<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-training\" data-pl-p=\"training\" hidden><span class=\"pl-anchor\" id=\"training\"><\/span><h3 class=\"ss-h3\">Capacitaciones<\/h3><p class=\"pl-d\">Capacitaciones a medida, con los documentos y los casos de su empresa, para que el equipo las aplique al d\u00eda siguiente.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Normalmente incluye<\/p><ul class=\"ss-check\"><li>Capacitaci\u00f3n in company<\/li><li>En l\u00ednea, en vivo<\/li><li>Talleres con sus documentos<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referencias<\/p><p class=\"pl-chips\"><span>ISO 13485<\/span><span>ISO 14971<\/span><span>MDR de la UE<\/span><span>RDC 665\/2022<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Hable con nosotros sobre esto \u2192<\/a><\/p><\/div><\/div><\/div><p class=\"pl-hint\">Toque un tema para ver los detalles.<\/p><\/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\">La referencia de calidad que cada autoridad suele usar<\/h2><p class=\"ss-sub\">Una base bien construida suele servir a varios mercados. Lo que cambia es la forma de demostrarlo.<\/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 aplica sus propias Buenas Pr\u00e1cticas de Fabricaci\u00f3n (RDC 665\/2022). Para productos de clases III y IV, el registro suele exigir el Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (CBPF), y los informes MDSAP pueden apoyar ese proceso.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Buenas Pr\u00e1cticas de Fabricaci\u00f3n para cosm\u00e9ticos (RDC 48\/2013).<\/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 que el fabricante mantenga un sistema de gesti\u00f3n de la calidad. La ISO 13485 es la norma armonizada m\u00e1s usada para demostrarlo, y el organismo notificado eval\u00faa el sistema seg\u00fan la clase y la v\u00eda elegida.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>El Reglamento (CE) 1223\/2009 exige Buenas Pr\u00e1cticas de Fabricaci\u00f3n, y la ISO 22716 es la referencia armonizada.<\/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 tiene reglas propias para productos sanitarios, aplicadas por la MHRA. La ISO 13485 suele ser la base del sistema evaluado por el organismo aprobado, o aceptado mediante el reconocimiento del marcado CE, seg\u00fan el caso.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Las reglas de cosm\u00e9ticos del Reino Unido exigen Buenas Pr\u00e1cticas de Fabricaci\u00f3n, y la ISO 22716 suele ser la referencia.<\/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>Desde febrero de 2026, el reglamento de la FDA para sistemas de calidad (QMSR) incorpora la ISO 13485:2016 por referencia, con algunos requisitos propios de la FDA.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>MoCRA prev\u00e9 reglas de Buenas Pr\u00e1cticas de Fabricaci\u00f3n de la FDA para cosm\u00e9ticos. Mientras tanto, la ISO 22716 suele ser la referencia.<\/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 suele exigir un certificado MDSAP para licencias de productos de clases II, III y IV.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>La ISO 22716 suele ser la referencia de buenas pr\u00e1cticas para cosm\u00e9ticos.<\/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-how\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">C\u00f3mo trabajamos<\/p><h2 class=\"ss-h2\">Del diagn\u00f3stico a la auditor\u00eda, 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>Diagn\u00f3stico<\/b><span>Entendemos el producto, los mercados y el sistema que usted ya tiene.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">2<\/span><b>Plan priorizado<\/b><span>Qu\u00e9 hacer primero, para qu\u00e9 mercado y con qu\u00e9 esfuerzo.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">3<\/span><b>Implementaci\u00f3n con su equipo<\/b><span>Documentos, procesos y capacitaci\u00f3n, al ritmo de la empresa.<\/span><em class=\"pl-who\">Sobel y usted<\/em><\/li><li><span class=\"ss-num\">4<\/span><b>Auditor\u00eda interna o simulada<\/b><span>Probamos el sistema antes de quien va a certificar o inspeccionar.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">5<\/span><b>Certificaci\u00f3n y mantenimiento<\/b><span>Apoyo en la auditor\u00eda o inspecci\u00f3n y en las acciones que vengan despu\u00e9s.<\/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\" 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-supplier-audit-1024x765.jpg\" class=\"ss-photo2\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-1024x765.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-300x224.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-768x574.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-1536x1147.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit.jpg 1600w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><div><p class=\"ss-eye\">Juntos desde el inicio<\/p><h2 class=\"ss-h2\">Estrategia regulatoria y evidencia de seguridad en el mismo plan<\/h2><p class=\"ss-sub\">Muchos retrasos empiezan cuando la estrategia regulatoria y la evidencia de seguridad se planifican por separado. En Sobel, los dos equipos trabajan sobre el mismo expediente.<\/p><div class=\"pl-clist\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/es\/evidencia-clinica-seguridad-producto\/\"><b>Evidencia Cl\u00ednica y Seguridad del Producto<\/b><span>Evaluaci\u00f3n biol\u00f3gica, toxicolog\u00eda y evaluaci\u00f3n cl\u00ednica.<\/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><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/producto-detenido-en-anvisa\/\"><b>\u00bfProducto detenido en ANVISA?<\/b><span>Rechazado, con requerimiento o parado.<\/span><em>\u2192<\/em><\/a><\/div><\/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 13485:2016 \u00b7 ISO 14971:2019 \u00b7 ISO 19011 \u00b7 ISO 22716 \u00b7 RDC 665\/2022 \u00b7 RDC 48\/2013 \u00b7 RDC 751\/2022 \u00b7 FDA QMSR \u00b7 MDSAP<\/p><\/div><div class=\"ss-faq\"><details open><summary>\u00bfSobel emite certificados ISO 13485 o MDSAP?<\/summary><p>No. La certificaci\u00f3n la realizan organismos de certificaci\u00f3n acreditados o, en el MDSAP, organizaciones auditoras reconocidas por las autoridades. Sobel prepara el sistema, la documentaci\u00f3n y el equipo para esa auditor\u00eda.<\/p><\/details><details><summary>\u00bfUn \u00fanico sistema de calidad puede atender a varios mercados?<\/summary><p>En general, s\u00ed. Una base ISO 13485 suele ser el punto de partida, y se le a\u00f1aden los requisitos propios de cada autoridad. Lo que cada mercado pide en su caso, lo confirmamos en su evaluaci\u00f3n.<\/p><\/details><details><summary>\u00bfRealizan auditor\u00edas de proveedores fuera de Brasil?<\/summary><p>S\u00ed. Las auditor\u00edas pueden ser presenciales, remotas o h\u00edbridas, seg\u00fan el proveedor y el riesgo involucrado.<\/p><\/details><details><summary>\u00bfAtienden a fabricantes de cosm\u00e9ticos?<\/summary><p>S\u00ed. Para cosm\u00e9ticos, trabajamos con Buenas Pr\u00e1cticas de Fabricaci\u00f3n y la ISO 22716, adem\u00e1s de auditor\u00edas de proveedores.<\/p><\/details><details><summary>\u00bfEn qu\u00e9 idiomas trabajan?<\/summary><p>En portugu\u00e9s, ingl\u00e9s y alem\u00e1n.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"\\u00bfSobel emite certificados ISO 13485 o MDSAP?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. La certificaci\\u00f3n la realizan organismos de certificaci\\u00f3n acreditados o, en el MDSAP, organizaciones auditoras reconocidas por las autoridades. 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