{"id":46401,"date":"2026-10-27T13:35:39","date_gmt":"2026-10-27T16:35:39","guid":{"rendered":"https:\/\/sobelconsult.com\/?page_id=46401"},"modified":"2026-10-27T13:35:40","modified_gmt":"2026-10-27T16:35:40","slug":"evidencia-clinica-seguranca-produto","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/evidencia-clinica-seguranca-produto\/","title":{"rendered":"Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto"},"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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Seguran\u00e7a do Produto<\/span><\/p><p class=\"ss-eye\">Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto<\/p><h1 class=\"ss-h1\">Evid\u00eancia de seguran\u00e7a planejada uma vez, <span>aproveitada<\/span> em cada mercado.<\/h1><p class=\"ss-lead\">Avalia\u00e7\u00e3o biol\u00f3gica, caracteriza\u00e7\u00e3o qu\u00edmica, toxicologia e avalia\u00e7\u00e3o cl\u00ednica constru\u00eddas como uma s\u00f3 linha de evid\u00eancia, alinhada \u00e0 estrat\u00e9gia regulat\u00f3ria desde o in\u00edcio.<\/p><div class=\"ss-btns\"><a class=\"ss-btn\" href=\"#footer-cta\">Agende sua avalia\u00e7\u00e3o<\/a><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\">Encontre seu caminho regulat\u00f3rio \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 no Brasil<\/li><li><i>\ud83c\udf10<\/i>Atendimento em 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=\"Especialista analisando dados de biocompatibilidade de um dispositivo m\u00e9dico\" 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\">\u00c9 para voc\u00ea?<\/p><h2 class=\"ss-h2\">Para quem fazemos isso<\/h2><\/div><div class=\"ss-g4\"><div class=\"ss-card\"><b>Produto novo, sem plano<\/b><span>Voc\u00ea precisa decidir quais ensaios fazer antes de gastar com laborat\u00f3rio.<\/span><\/div><div class=\"ss-card\"><b>Arquivo anterior a 2025<\/b><span>Sua avalia\u00e7\u00e3o biol\u00f3gica precisa ser revista frente \u00e0 ISO 10993-1:2025.<\/span><\/div><div class=\"ss-card\"><b>Exig\u00eancia de autoridade<\/b><span>A autoridade questionou a biocompatibilidade ou a evid\u00eancia cl\u00ednica.<\/span><\/div><div class=\"ss-card\"><b>Novo mercado<\/b><span>Voc\u00ea quer aproveitar relat\u00f3rios existentes em outro 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\">Em n\u00fameros<\/p><h2 class=\"ss-h2\">O que os dados mostram<\/h2><\/div><div class=\"pl-nums\"><div class=\"pl-num\"><b>39%<\/b><strong>dos pedidos MDR recusados<\/strong><span>foram recusados por estarem incompletos, o motivo mais comum na pesquisa da Comiss\u00e3o Europeia com organismos notificados.<\/span><\/div><div class=\"pl-num\"><b>13 a 18<\/b><strong>meses \u00e9 o prazo mais comum at\u00e9 um novo certificado MDR<\/strong><span>para novos certificados emitidos em 2025 (48% dos casos). Um arquivo completo desde o in\u00edcio pesa nesse tempo.<\/span><\/div><div class=\"pl-num\"><b>6\u00aa<\/b><strong>edi\u00e7\u00e3o da ISO 10993-1, publicada em 2025<\/strong><span>A nova edi\u00e7\u00e3o integra a avalia\u00e7\u00e3o biol\u00f3gica ao gerenciamento de risco da ISO 14971.<\/span><\/div><\/div><p class=\"pl-src\">Fontes: Comiss\u00e3o Europeia, pesquisa com organismos notificados (dados at\u00e9 fevereiro de 2025); Team-NB, pesquisa com organismos notificados europeus, dados 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\">A cadeia da evid\u00eancia<\/p><h2 class=\"ss-h2\">Cada etapa alimenta a pr\u00f3xima<\/h2><p class=\"ss-sub\">Planejar a sequ\u00eancia evita ensaios repetidos e relat\u00f3rios que n\u00e3o conversam entre si.<\/p><\/div><div class=\"pl-seg\" role=\"group\"><button type=\"button\" class=\"pl-sb on\" data-pl-seg=\"md\" aria-pressed=\"true\">Dispositivos m\u00e9dicos<\/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>Avalia\u00e7\u00e3o 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>Caracteriza\u00e7\u00e3o 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>Avalia\u00e7\u00e3o de risco 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>Avalia\u00e7\u00e3o cl\u00ednica<\/b><small>EU MDR \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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Para dispositivos em contato com o corpo, como parte do arquivo t\u00e9cnico.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Fale com a gente sobre isso \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Plano de avalia\u00e7\u00e3o biol\u00f3gica (BEP)<\/li><li>Relat\u00f3rio de avalia\u00e7\u00e3o biol\u00f3gica (BER)<\/li><li>An\u00e1lise de lacunas frente \u00e0 ISO 10993-1:2025<\/li><li>Estrat\u00e9gia de ensaios e coordena\u00e7\u00e3o com laborat\u00f3rios<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Quando \u00e9 preciso conhecer o que o material pode liberar, como extra\u00edveis e lixivi\u00e1veis.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Fale com a gente sobre isso \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Estrat\u00e9gia de caracteriza\u00e7\u00e3o qu\u00edmica<\/li><li>Plano de extra\u00edveis e lixivi\u00e1veis<\/li><li>Interpreta\u00e7\u00e3o dos resultados do laborat\u00f3rio<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Quando os dados qu\u00edmicos precisam ser avaliados quanto ao risco para o paciente.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Fale com a gente sobre isso \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Relat\u00f3rio de avalia\u00e7\u00e3o de risco toxicol\u00f3gico<\/li><li>Margem de seguran\u00e7a por subst\u00e2ncia<\/li><li>Justificativa para dispensar ensaios, quando cab\u00edvel<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Para demonstrar seguran\u00e7a e desempenho com dados cl\u00ednicos, conforme a classe e o mercado.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/avaliacao-clinica-anvisa\/\">Avalia\u00e7\u00e3o cl\u00ednica \u00b7 Brasil \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Plano e relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica<\/li><li>Revis\u00e3o sistem\u00e1tica da literatura<\/li><li>An\u00e1lise de equival\u00eancia, quando aplic\u00e1vel<\/li><li>Base para o acompanhamento p\u00f3s-mercado<\/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 subst\u00e2ncias 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>Avalia\u00e7\u00e3o de seguran\u00e7a<\/b><small>CPSR (UE e Reino Unido) \u00b7 MoCRA (EUA)<\/small><\/button><button type=\"button\" role=\"tab\" class=\"pl-st\" aria-selected=\"false\" data-pl-t=\"cosmetovigilance\"><i>3<\/i><b>P\u00f3s-mercado<\/b><small>Cosmetovigil\u00e2ncia<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Antes de notificar ou registrar, para conferir ingredientes e concentra\u00e7\u00f5es em cada mercado.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/pt-br\/registro-de-cosmeticos-anvisa\/\">Cosm\u00e9ticos \u00b7 Brasil \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Revis\u00e3o da f\u00f3rmula frente \u00e0s listas de cada mercado<\/li><li>Pontos de aten\u00e7\u00e3o por ingrediente<\/li><li>Apoio na rotulagem<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Para demonstrar a seguran\u00e7a do produto antes de coloc\u00e1-lo no mercado.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Fale com a gente sobre isso \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Apoio na avalia\u00e7\u00e3o de seguran\u00e7a<\/li><li>Coordena\u00e7\u00e3o do relat\u00f3rio de seguran\u00e7a com avaliador qualificado<\/li><li>Dados de seguran\u00e7a para a notifica\u00e7\u00e3o<\/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\">Quando costuma ser pedido<\/p><p class=\"pl-d\">Depois do lan\u00e7amento, para acompanhar efeitos indesej\u00e1veis e mudan\u00e7as de f\u00f3rmula.<\/p><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Fale com a gente sobre isso \u2192<\/a><\/p><\/div><div><p class=\"pl-lbl\">Normalmente inclui<\/p><ul class=\"ss-check\"><li>Rotina de cosmetovigil\u00e2ncia<\/li><li>Avalia\u00e7\u00e3o de mudan\u00e7as de f\u00f3rmula<\/li><li>Apoio nas comunica\u00e7\u00f5es com a autoridade<\/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\">Em cada mercado<\/p><h2 class=\"ss-h2\">O que cada autoridade costuma olhar<\/h2><p class=\"ss-sub\">A base cient\u00edfica \u00e9 a mesma. O que muda \u00e9 o formato e o n\u00edvel de evid\u00eancia que cada mercado pede.<\/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\u00e3o Europeia<\/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>EUA<\/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\">Dispositivos m\u00e9dicos<\/p><p>A ANVISA costuma pedir a avalia\u00e7\u00e3o biol\u00f3gica no dossi\u00ea t\u00e9cnico e evid\u00eancia cl\u00ednica proporcional \u00e0 classe e ao risco do dispositivo.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Para cosm\u00e9ticos, a empresa respons\u00e1vel mant\u00e9m os dados de seguran\u00e7a do produto, e a cosmetovigil\u00e2ncia acompanha o p\u00f3s-mercado.<\/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\u00e3o Europeia \u00b7 EU MDR<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Dispositivos m\u00e9dicos<\/p><p>O MDR exige avalia\u00e7\u00e3o cl\u00ednica para todos os dispositivos, atualizada ao longo do ciclo de vida. A biocompatibilidade costuma ser avaliada pela s\u00e9rie ISO 10993.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>Cada cosm\u00e9tico precisa de um relat\u00f3rio de seguran\u00e7a (CPSR) assinado por avaliador qualificado, mantido no arquivo de informa\u00e7\u00f5es do produto.<\/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\">Dispositivos m\u00e9dicos<\/p><p>O Reino Unido segue uma l\u00f3gica semelhante: avalia\u00e7\u00e3o biol\u00f3gica pela s\u00e9rie ISO 10993 e evid\u00eancia cl\u00ednica conforme a classe.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>As regras do Reino Unido tamb\u00e9m pedem um relat\u00f3rio de seguran\u00e7a do produto 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>EUA \u00b7 FDA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Dispositivos m\u00e9dicos<\/p><p>O FDA tem orienta\u00e7\u00e3o pr\u00f3pria sobre o uso da ISO 10993-1, e a necessidade de dados cl\u00ednicos depende da via: 510(k), De Novo ou PMA.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>O MoCRA exige que o respons\u00e1vel mantenha a comprova\u00e7\u00e3o da seguran\u00e7a 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\">Dispositivos m\u00e9dicos<\/p><p>A Health Canada pede evid\u00eancia de seguran\u00e7a e efic\u00e1cia proporcional \u00e0 classe, e a s\u00e9rie ISO 10993 costuma ser a refer\u00eancia para biocompatibilidade.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Cosm\u00e9ticos<\/p><p>O fabricante responde pela seguran\u00e7a do cosm\u00e9tico e notifica o produto \u00e0 Health Canada.<\/p><\/div><\/div><\/div><p class=\"pl-note\">A exig\u00eancia exata depende do produto, da classe e da via escolhida. Confirmamos na sua avalia\u00e7\u00e3o.<\/p><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-team\"><div class=\"ss-in pl-team\"><div><p class=\"ss-eye\">Dois times, um s\u00f3 dossi\u00ea<\/p><h2 class=\"ss-h2\">Regulat\u00f3rio e Qualidade \u00d7 Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto<\/h2><p class=\"ss-sub\">A estrat\u00e9gia regulat\u00f3ria define o que cada mercado vai pedir. A evid\u00eancia de seguran\u00e7a mostra que o produto atende. Quando os dois times planejam juntos, cada ensaio e cada relat\u00f3rio j\u00e1 nascem com destino certo.<\/p><\/div><ol class=\"pl-meet\"><li><i>1<\/i><span>Classifica\u00e7\u00e3o e uso pretendido<\/span><\/li><li><i>2<\/i><span>Plano de evid\u00eancia por mercado<\/span><\/li><li><i>3<\/i><span>Escolha de ensaios e laborat\u00f3rios<\/span><\/li><li><i>4<\/i><span>Respostas \u00e0s 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\">Como trabalhamos<\/p><h2 class=\"ss-h2\">Da revis\u00e3o do material ao relat\u00f3rio, em cinco etapas<\/h2><p class=\"ss-sub\">Voc\u00ea acompanha cada etapa no Sobel Client Workspace.<\/p><\/div><ol class=\"ss-steps pl-how\"><li><span class=\"ss-num\">1<\/span><b>Revis\u00e3o do produto e dos materiais<\/b><span>Uso pretendido, contato com o corpo, materiais e o que j\u00e1 existe.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">2<\/span><b>Plano de evid\u00eancia<\/b><span>O que pode ser aproveitado e o que precisa ser complementado.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">3<\/span><b>Ensaios com laborat\u00f3rios qualificados<\/b><span>Coordenamos o laborat\u00f3rio que voc\u00ea escolher ou que indicarmos.<\/span><em class=\"pl-who\">Sobel e laborat\u00f3rio<\/em><\/li><li><span class=\"ss-num\">4<\/span><b>Relat\u00f3rios<\/b><span>Relat\u00f3rios no formato que cada autoridade costuma pedir.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">5<\/span><b>Apoio nas perguntas da autoridade<\/b><span>Respostas t\u00e9cnicas \u00e0s exig\u00eancias, junto com a sua equipe.<\/span><em class=\"pl-who\">Sobel e voc\u00ea<\/em><\/li><\/ol><p class=\"ss-c ss-after\"><a class=\"ss-btn\" href=\"#footer-cta\">Fale com um 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\">Continue explorando<\/h2><div class=\"pl-clist\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/regulatorio-qualidade\/\"><b>Regulat\u00f3rio e Qualidade<\/b><span>Registro, sistemas da qualidade, risco e auditorias.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/avaliacao-clinica-anvisa\/\"><b>Avalia\u00e7\u00e3o cl\u00ednica \u00b7 Brasil<\/b><span>Evid\u00eancia cl\u00ednica para o registro na ANVISA.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/\"><b>Sobel Route<\/b><span>Veja o que fazemos em cada mercado e monte o seu caminho.<\/span><em>\u2192<\/em><\/a><\/div><a class=\"pl-free\" href=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/https-sobelconsult-com-pt-br-materiais-iso-10993-12025-guide\/\"><small>Material gratuito<\/small><b>E-book ISO 10993-1:2025<\/b><span>O que mudou na nova edi\u00e7\u00e3o e como revisar a sua avalia\u00e7\u00e3o biol\u00f3gica.<\/span><em>Baixar \u2192<\/em><\/a><\/div><\/div><\/section><div class=\"ss-why\">\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46192\" class=\"elementor elementor-46192 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\">Por que a 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\">A regulamenta\u00e7\u00e3o como uma <span class=\"sbw-gold\">decis\u00e3o<\/span> de neg\u00f3cios <span class=\"sbw-gold\">,<\/span> n\u00e3o como uma lista de verifica\u00e7\u00e3o.<\/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>Quatro \u00e1reas trabalham juntas em cada projeto, na mesma equipe, desde a primeira decis\u00e3o at\u00e9 a fase p\u00f3s-lan\u00e7amento.<\/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\">Estrat\u00e9gia<\/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>Primeiro, decide-se a classifica\u00e7\u00e3o e a sequ\u00eancia de mercado. Escolher a classe certa desde o in\u00edcio evita ter que refazer o trabalho.<\/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\">Ci\u00eancia em casa<\/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>Avalia\u00e7\u00e3o biol\u00f3gica, cl\u00ednica e toxicol\u00f3gica feita pela nossa pr\u00f3pria equipe de Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<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\">Regulat\u00f3rio, 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>A ANVISA, a FDA, o MDR e o IVDR da UE, a MHRA e a Health Canada trabalharam em conjunto.<\/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\">Tecnologia<\/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>Uma equipe de tecnologia especializada cria os fluxos de trabalho que garantem que cada projeto seja rastre\u00e1vel e seja conclu\u00eddo dentro do prazo.<\/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>\u201cSabemos como os auditores pensam, porque j\u00e1 fomos um deles.\u201d<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-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-44766\" 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 e CEO<\/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>Engenheiro mec\u00e2nico, formado na Alemanha<\/li><li>Ex-auditor da BSI (\u00d3rg\u00e3o Notificado)<\/li><li>Experi\u00eancia no setor nas empresas Sirona e 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\/pt-br\/home\/about-us\/\">\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\">Conhe\u00e7a a equipe \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\">Perguntas e respostas<\/p><h2 class=\"ss-h2\">Perguntas frequentes<\/h2><p class=\"ss-rules\"><b>Normas citadas nesta p\u00e1gina:<\/b> ISO 10993-1:2025 \u00b7 ISO 10993-17 \u00b7 ISO 10993-18 \u00b7 ISO 14971:2019 \u00b7 EU MDR \u00b7 Regulamento (CE) 1223\/2009 \u00b7 MoCRA<\/p><\/div><div class=\"ss-faq\"><details open><summary>A Sobel realiza os ensaios de laborat\u00f3rio?<\/summary><p>N\u00e3o. Os ensaios s\u00e3o feitos por laborat\u00f3rios qualificados, que voc\u00ea escolhe ou que indicamos. A Sobel planeja a estrat\u00e9gia, coordena o laborat\u00f3rio e interpreta os resultados.<\/p><\/details><details><summary>Preciso refazer ensaios por causa da ISO 10993-1:2025?<\/summary><p>Nem sempre. Em geral, uma an\u00e1lise de lacunas mostra o que pode ser aproveitado e o que precisa ser complementado. Confirmamos na sua avalia\u00e7\u00e3o.<\/p><\/details><details><summary>Um mesmo relat\u00f3rio pode servir a v\u00e1rios mercados?<\/summary><p>Costuma ser poss\u00edvel partir de uma base comum e adapt\u00e1-la ao formato e ao n\u00edvel de evid\u00eancia que cada autoridade pede.<\/p><\/details><details><summary>Voc\u00eas fazem avalia\u00e7\u00e3o cl\u00ednica?<\/summary><p>Sim, para dispositivos m\u00e9dicos, com revis\u00e3o da literatura e an\u00e1lise de equival\u00eancia quando aplic\u00e1vel, alinhada ao que cada mercado costuma pedir.<\/p><\/details><details><summary>Voc\u00eas avaliam a seguran\u00e7a de cosm\u00e9ticos?<\/summary><p>Apoiamos a avalia\u00e7\u00e3o de seguran\u00e7a e coordenamos o relat\u00f3rio com avaliador qualificado, conforme as regras de cada mercado.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"A Sobel realiza os ensaios de laborat\\u00f3rio?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"N\\u00e3o. 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