{"id":41040,"date":"2026-07-12T09:29:19","date_gmt":"2026-07-12T12:29:19","guid":{"rendered":"https:\/\/sobelconsult.com\/nuestras-soluciones-2\/"},"modified":"2026-11-05T09:02:17","modified_gmt":"2026-11-05T12:02:17","slug":"nuestras-soluciones-2","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/","title":{"rendered":"Nuestras soluciones"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"41040\" class=\"elementor elementor-41040 elementor-41002\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-582d7cd1 e-flex e-con-boxed e-con e-parent\" data-id=\"582d7cd1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-69b72515 elementor-widget elementor-widget-shortcode\" data-id=\"69b72515\" data-element_type=\"widget\" data-e-type=\"widget\" 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.sr-chips{margin-top:0;flex-wrap:nowrap;flex-direction:column;align-items:flex-start}\n.sr-rl{font-size:12px;font-weight:700;letter-spacing:.1em;text-transform:uppercase;color:#4F535B;margin-right:4px}\n.sr-route{margin:0}\n.sr-pill{font-size:18px;padding:5px 14px 5px 10px}\n.sr-sechead .sr-sub{max-width:none}\n@media (min-width:1025px) and (max-height:840px){.sr-steps{padding:16px 20px}.sr-from,.sr-dest{padding:10px 12px}.sr button.sr-chip{min-height:34px!important;padding:6px 13px!important}.sr-pill{font-size:17px}}\n@media (max-width:1180px){.sr-s1 .sr-chips{flex-direction:row;flex-wrap:wrap}}\n\n\/* v2d fit *\/\n.sr-sec{padding:44px 0}\n.sr-sechead{margin-bottom:22px}\n.sr-gstack{gap:12px}\n#sr-all .sr-wheelcol{max-width:500px}\n@media (min-width:1025px) and (max-height:840px){.sr-sec{padding:32px 0}.sr-sechead{margin-bottom:16px}.sr-h2s{font-size:30px;margin-top:10px}#sr-all .sr-wheelcol{max-width:420px}.sr-hint{margin-top:4px}.sr-legend{margin-top:8px}}\n@media (min-width:1025px) and (max-height:700px){#sr-all .sr-wheelcol{max-width:380px}.sr-h2s{font-size:28px}}\n@media (max-width:1024px){.sr-sec{padding:48px 0}}\n.sr-white .sr-res{padding:18px 24px 20px}\n.sr-rgrid{margin-top:12px}\n.sr-box ul{gap:4px}\n.sr-bs{margin-bottom:8px}\n@media (min-width:1025px) and (max-height:840px){.sr-white .sr-res{padding:14px 20px 16px}.sr-rgrid{margin-top:10px}.sr-box{padding:10px 12px 12px}.sr-box ul{gap:3px}.sr-tile{padding:8px 12px}.sr-side .sr-tiles{gap:8px}.sr-gstack{gap:10px}}\n@media (max-width:1180px){.sr-steps{grid-template-columns:1fr 1fr!important}}\n@media (max-width:767px){.sr-steps{grid-template-columns:1fr!important}.sr-s1 .sr-chips{flex-direction:row}.sr-route{gap:8px}.sr-route .sr-rl{width:100%}}\n<\/style><div class=\"sr\" id=\"sr-app\" data-lang=\"es\">\n<section class=\"sr-hero sr-wrap\" id=\"sr-top\">\n<p class=\"sr-crumb\"><a href=\"https:\/\/sobelconsult.com\/es\/\">Inicio<\/a> \u203a <span class=\"cur\">Soluciones<\/span><\/p>\n<p class=\"sr-eye\">Soluciones \u00b7 Brasil, UE, Reino Unido, EE. UU., Canad\u00e1<\/p>\n<h1 class=\"sr-h1\">Encuentre su ruta <span>regulatoria<\/span><\/h1>\n<p class=\"sr-lead\">Vea lo que hacemos en cada mercado y arme la ruta de su producto.<\/p>\n<nav class=\"sr-jump\" aria-label=\"Sobel Route\"><a href=\"#sr-all\"><b>1<\/b>Lo que hacemos<\/a><a href=\"#sr-guide-sec\"><b>2<\/b>Arme su ruta<\/a><\/nav>\n<\/section>\n<section class=\"sr-sec\" id=\"sr-all\">\n<div class=\"sr-wrap\">\n<div class=\"sr-sechead\"><p class=\"sr-eye\">1 \u00b7 Lo que hacemos<\/p><h2 class=\"sr-h2s\">Servicios por segmento y mercado<\/h2><\/div>\n<div class=\"sr-split\">\n<div class=\"sr-wheelcol\"><div id=\"sr-wheelbox\"><\/div>\n<div class=\"sr-legend\"><span><i style=\"background:#F2B705\"><\/i>Todos los mercados<\/span><span><i style=\"background:#2A72C8\"><\/i>Productos sanitarios<\/span><span><i style=\"background:#149189\"><\/i>IVD<\/span><span><i style=\"background:#9471CF\"><\/i>Cosm\u00e9ticos<\/span><\/div>\n<p class=\"sr-hint\">El anillo dorado muestra lo que aplica a todo producto y mercado. Pase el cursor o toque un mercado para ver los servicios.<\/p><\/div>\n<div class=\"sr-card sr-wcard\" id=\"sr-wcard\" aria-live=\"polite\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sr-sec sr-white\" id=\"sr-guide-sec\">\n<div class=\"sr-wrap\">\n<div class=\"sr-sechead\"><p class=\"sr-eye\">2 \u00b7 Su ruta<\/p><h2 class=\"sr-h2s\">Arme la ruta de su producto<\/h2><\/div>\n<div class=\"sr-gstack\" id=\"sr-guide\">\n<div class=\"sr-card sr-steps\">\n<div class=\"sr-step sr-s1\"><p class=\"sr-lbl\"><b>1<\/b>Su producto<\/p><div class=\"sr-chips\" id=\"sr-q1\"><\/div><\/div>\n<div class=\"sr-step sr-from\"><p class=\"sr-lbl\"><b>2<\/b>Lo que usted ya tiene<\/p><div class=\"sr-chips\" id=\"sr-q2\"><\/div><\/div>\n<div class=\"sr-arrow\" aria-hidden=\"true\"><svg viewBox=\"0 0 24 24\" width=\"26\" height=\"26\"><path d=\"M4 12h15M13 6l6 6-6 6\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg><\/div>\n<div class=\"sr-step sr-dest\"><p class=\"sr-lbl\"><b>3<\/b>A d\u00f3nde quiere ir<\/p><div class=\"sr-chips\" id=\"sr-q3\"><\/div><\/div>\n<\/div>\n<div class=\"sr-card sr-res\" id=\"sr-res\" aria-live=\"polite\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<script>window.SR_TX = window.SR_TX || {};\nSR_TX.en = {\"crumbHome\":\"Home\",\"crumbCur\":\"Solutions\",\"eyebrow\":\"Solutions \u00b7 Brazil, EU, UK, USA, Canada\",\"h1a\":\"Find your regulatory \",\"h1b\":\"path\",\"lead\":\"Answer three questions, or see everything we do in every market.\",\"modeGuide\":\"Guide me\",\"modeAll\":\"Show me everything\",\"q1\":\"1 \u00b7 Your product\",\"q2\":\"2 \u00b7 Where is it today?\",\"q3\":\"3 \u00b7 Where do you want to go?\",\"yourPath\":\"Your path\",\"toolName\":\"Sobel Route\",\"seg\":{\"md\":\"Medical devices\",\"ivd\":\"IVD\",\"cos\":\"Cosmetics\"},\"segShort\":{\"md\":[\"Medical\",\"devices\"],\"ivd\":[\"IVD\"],\"cos\":[\"Cosmetics\"]},\"mk\":{\"br\":\"Brazil\",\"eu\":\"European Union\",\"uk\":\"United Kingdom\",\"us\":\"USA\",\"ca\":\"Canada\"},\"mkShort\":{\"br\":\"Brazil\",\"eu\":\"EU\",\"uk\":\"UK\",\"us\":\"USA\",\"ca\":\"Canada\"},\"from\":{\"none\":\"Not on the market yet\",\"br\":\"Brazil\",\"eu\":\"European Union (CE)\",\"us\":\"USA (FDA)\",\"ca\":\"Canada\"},\"firstMarket\":\"First market: \",\"already\":\" already on the market: \",\"reuseLabel\":\"Usually reusable, with adaptation\",\"includesLabel\":\"What the route includes\",\"alwaysNew\":\"Usually new for \",\"nextLabel\":\"What usually comes next\",\"next\":[\"Changes, renewals and new products\",\"Post-market surveillance and vigilance\",\"Ongoing regulatory support\"],\"techLabel\":\"Technical confirmation\",\"cta\":\"Talk to a specialist\",\"open\":\"Open \",\"see\":\"See how we work\",\"notOffered\":\"Not offered today\",\"ivdOnly\":\"Today Sobel supports IVDs in Brazil only. 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An approval from another country usually does not transfer by itself: our team confirms each item against the destination\u2019s rules before you plan on it.\",\"ivd\":\"In Brazil the class follows the intended use in your instructions, not only the analyte. Performance data must cover the claims, specimens and users you declare in Brazil. Our team confirms class and evidence before any document is prepared.\",\"cos\":\"Each market keeps its own lists of banned and restricted ingredients and its own rules for claims. A product compliant in one market may need a formula, label or claim change in another. Our team confirms the formula ingredient by ingredient before you plan.\"},\"extra\":{\"reliance\":\"Under IN 290\/2024, ANVISA may take into account a prior approval by FDA, Health Canada, TGA or Japan\u2019s MHLW for some Class III and IV devices and IVDs. 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Passe o mouse ou toque em qualquer parte para explorar.\",\"acrossEye\":\"Todos os mercados\",\"acrossReg\":\"Dispositivos m\u00e9dicos \u00b7 IVD \u00b7 Cosm\u00e9ticos\",\"acrossNote\":\"Dispon\u00edvel para os segmentos e mercados, definido caso a caso.\",\"segEye\":\"Segmento\",\"segReg\":\"Cinco mercados, uma estrat\u00e9gia\",\"segNote\":\"Escolha um mercado no anel externo para ver os servi\u00e7os.\",\"mktNote\":\"Cada servi\u00e7o \u00e9 definido para o seu produto, com etapas e responsabilidades acordadas desde o in\u00edcio.\",\"askNote\":\"Definimos este mercado caso a caso com a nossa equipe regulat\u00f3ria.\",\"openMarket\":\"Abrir a p\u00e1gina do mercado\",\"acrossTitle\":\"Para todos os mercados\",\"across\":{\"audits\":{\"t\":\"Auditorias\",\"d\":\"Auditorias internas, de fornecedores e simula\u00e7\u00f5es de certifica\u00e7\u00e3o\",\"items\":[\"Auditorias internas: ISO 13485, ISO 9001, MDSAP\",\"Auditorias de fornecedores\",\"Simula\u00e7\u00f5es de auditoria de certifica\u00e7\u00e3o\",\"Presencial, remota ou h\u00edbrida\"]},\"qs\":{\"t\":\"Sistemas da qualidade\",\"d\":\"ISO 13485, MDSAP, FDA QMSR, BPF ANVISA, ISO 22716\",\"items\":[\"ISO 13485 e MDSAP\",\"FDA QMSR\",\"BPF ANVISA (RDC 665\/2022)\",\"ISO 22716 para cosm\u00e9ticos\"]},\"training\":{\"t\":\"Treinamentos\",\"d\":\"Treinamentos in company para equipes regulat\u00f3rias e da qualidade\",\"items\":[\"Treinamentos in company\",\"Online, ao vivo\",\"Workshops com os seus documentos\"]}},\"reg\":{\"md\":{\"br\":\"ANVISA \u00b7 RDC 751\/2022\",\"eu\":\"MDR (UE) 2017\/745\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"ivd\":{\"br\":\"ANVISA \u00b7 RDC 830\/2023\",\"eu\":\"IVDR (UE) 2017\/746\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"cos\":{\"br\":\"ANVISA \u00b7 RDC 907\/2024\",\"eu\":\"Regulamento (CE) 1223\/2009\",\"uk\":\"UK Cosmetics Regulation\",\"us\":\"FDA \u00b7 MoCRA\",\"ca\":\"Health Canada \u00b7 Cosmetic Regulations\"}},\"sv\":{\"md\":{\"br\":[\"Notifica\u00e7\u00e3o ou registro na ANVISA\",\"Detentor do registro, por meio do nosso parceiro homologado\",\"Avalia\u00e7\u00e3o biol\u00f3gica\",\"Avalia\u00e7\u00e3o cl\u00ednica\",\"Apoio em ANATEL e INMETRO\"],\"eu\":[\"Apoio \u00e0 marca\u00e7\u00e3o CE\",\"Apoio com o Representante Autorizado na UE\",\"Avalia\u00e7\u00e3o biol\u00f3gica\",\"Avalia\u00e7\u00e3o cl\u00ednica\"],\"uk\":\"ask\",\"us\":[\"Consultoria regulat\u00f3ria FDA\",\"Apoio com o US Agent\",\"Avalia\u00e7\u00e3o biol\u00f3gica\"],\"ca\":[\"Licen\u00e7a Health Canada\",\"Avalia\u00e7\u00e3o biol\u00f3gica\"]},\"ivd\":{\"br\":[\"Notifica\u00e7\u00e3o ou registro de IVD\",\"Detentor do registro, por meio do nosso parceiro homologado\"],\"eu\":null,\"uk\":null,\"us\":null,\"ca\":null},\"cos\":{\"br\":[\"Notifica\u00e7\u00e3o e registro\",\"Detentor, por meio do nosso parceiro homologado\"],\"eu\":[\"Apoio \u00e0 notifica\u00e7\u00e3o CPNP; coordena\u00e7\u00e3o do relat\u00f3rio de seguran\u00e7a\",\"Apoio com a Pessoa Respons\u00e1vel na UE\",\"Product Information File\"],\"uk\":\"ask\",\"us\":[\"Registro e listagem MoCRA\",\"Apoio com o US Agent\",\"Comprova\u00e7\u00e3o de seguran\u00e7a\"],\"ca\":[\"Notifica\u00e7\u00e3o de cosm\u00e9tico\",\"Apoio na avalia\u00e7\u00e3o de seguran\u00e7a\"]}},\"reuse\":{\"md\":[\"Documenta\u00e7\u00e3o t\u00e9cnica, adaptada ao novo formato\",\"Arquivo de gerenciamento de risco (ISO 14971)\",\"Avalia\u00e7\u00e3o biol\u00f3gica (ISO 10993)\",\"Relat\u00f3rios de ensaios de bancada, el\u00e9tricos e de software\",\"Dados cl\u00ednicos, reavaliados pelas novas regras\",\"Sistema da qualidade ISO 13485 e relat\u00f3rios de auditoria MDSAP, quando aceitos\"],\"ivd\":[\"Documenta\u00e7\u00e3o t\u00e9cnica\",\"Dados de desempenho anal\u00edtico e cl\u00ednico\",\"Dados de estabilidade\",\"Arquivo de gerenciamento de risco (ISO 14971)\",\"Sistema da qualidade ISO 13485 e relat\u00f3rios de auditoria MDSAP, quando aceitos\"],\"cos\":[\"Dados da f\u00f3rmula e dos ingredientes (INCI)\",\"Dados e estudos de seguran\u00e7a\",\"Dados de estabilidade e compatibilidade\",\"Estudos que comprovam as suas alega\u00e7\u00f5es\"]},\"fresh\":{\"md\":{\"br\":[\"Classe pela RDC 751\/2022: notifica\u00e7\u00e3o (classes I\u2013II) ou registro (classes III\u2013IV)\",\"Detentor do registro com AFE, por meio do nosso parceiro homologado\",\"Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o da ANVISA (CBPF) para classes III e IV\",\"Rotulagem e instru\u00e7\u00f5es de uso em portugu\u00eas\",\"Certifica\u00e7\u00e3o INMETRO para equipamentos el\u00e9tricos, quando aplic\u00e1vel\"],\"eu\":[\"Classe pelo MDR e, para a maioria das classes, avalia\u00e7\u00e3o por Organismo Notificado\",\"Representante Autorizado na UE (para fabricantes de fora da UE) e pessoa respons\u00e1vel pelo cumprimento regulamentar\",\"Avalia\u00e7\u00e3o cl\u00ednica pelo MDR, normalmente com acompanhamento cl\u00ednico p\u00f3s-mercado\",\"Checklist de requisitos de seguran\u00e7a e desempenho, plano e relat\u00f3rios de vigil\u00e2ncia p\u00f3s-mercado\",\"UDI, registro no EUDAMED e rotulagem no idioma de cada pa\u00eds\"],\"uk\":[\"UK Responsible Person para fabricantes fora do Reino Unido\",\"Registro na MHRA antes de colocar no mercado da Gr\u00e3-Bretanha\",\"Marca\u00e7\u00e3o CE ou UKCA na Gr\u00e3-Bretanha pelas regras atuais; a Irlanda do Norte segue as regras da UE\",\"Vigil\u00e2ncia p\u00f3s-mercado pelas regras atuais da Gr\u00e3-Bretanha\"],\"us\":[\"Classe e via, como isento, 510(k), De Novo ou PMA\",\"Registro do estabelecimento, listagem do dispositivo e US Agent para estabelecimentos estrangeiros\",\"Sistema da qualidade pelo QMSR (21 CFR 820, que incorpora a ISO 13485)\",\"Ensaios espec\u00edficos do FDA, quando necess\u00e1rios, e, para 510(k) ou De Novo, submiss\u00e3o em eSTAR\",\"Rotulagem dos EUA, UDI quando aplic\u00e1vel e notifica\u00e7\u00e3o de eventos adversos\"],\"ca\":[\"Medical Device Licence para classes II\u2013IV; as licen\u00e7as de estabelecimento (MDEL) dependem da classe e do papel de cada empresa\",\"Certificado MDSAP para pedidos de licen\u00e7a das classes II\u2013IV\",\"Rotulagem em ingl\u00eas ou franc\u00eas; algumas informa\u00e7\u00f5es nos dois idiomas para produtos vendidos ao p\u00fablico\",\"Notifica\u00e7\u00e3o obrigat\u00f3ria de problemas\"]},\"ivd\":{\"br\":[\"Classe pelo uso pretendido, conforme a RDC 830\/2023: notifica\u00e7\u00e3o (classes I\u2013II) ou registro (classes III\u2013IV)\",\"Detentor do registro com AFE, por meio do nosso parceiro homologado\",\"Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o da ANVISA (CBPF) para classes III e IV\",\"Rotulagem e instru\u00e7\u00f5es em portugu\u00eas: impressas para alguns usos, como autotestes; em formato eletr\u00f4nico em outros casos, sob condi\u00e7\u00f5es\",\"An\u00e1lise pr\u00e9via em laborat\u00f3rio oficial brasileiro, quando exigida para o produto\"]},\"cos\":{\"br\":[\"Empresa brasileira com AFE como detentora, por meio do nosso parceiro homologado\",\"Notifica\u00e7\u00e3o pr\u00e9via para a maioria dos produtos; registro para algumas categorias, como protetores solares, repelentes, alisantes ou onduladores de cabelo, bronzeadores e gel antiss\u00e9ptico para as m\u00e3os\",\"F\u00f3rmula conferida com as listas de ingredientes do Brasil\",\"Rotulagem em portugu\u00eas, incluindo a lista de ingredientes\"],\"eu\":[\"Pessoa Respons\u00e1vel na UE\",\"Notifica\u00e7\u00e3o no CPNP antes de colocar no mercado\",\"Product Information File, incluindo relat\u00f3rio de seguran\u00e7a assinado por avaliador de seguran\u00e7a qualificado\",\"Rotulagem no idioma exigido por cada pa\u00eds; sem testes em animais para cumprir os requisitos de cosm\u00e9ticos\"],\"uk\":[\"UK Responsible Person, indicada no r\u00f3tulo\",\"Notifica\u00e7\u00e3o no SCPN para a Gr\u00e3-Bretanha; a Irlanda do Norte segue as regras da UE\",\"Product Information File e relat\u00f3rio de seguran\u00e7a dispon\u00edveis no Reino Unido\",\"Informa\u00e7\u00f5es obrigat\u00f3rias do r\u00f3tulo em ingl\u00eas\"],\"us\":[\"Registro da f\u00e1brica e listagem dos produtos, salvo isen\u00e7\u00e3o\",\"US Agent para f\u00e1bricas fora dos EUA\",\"Comprova\u00e7\u00e3o de seguran\u00e7a pela pessoa respons\u00e1vel\",\"Notifica\u00e7\u00e3o de eventos adversos graves e rotulagem dos EUA\"],\"ca\":[\"Cosmetic Notification Form ap\u00f3s a primeira venda, dentro do prazo previsto\",\"F\u00f3rmula conferida com a Cosmetic Ingredient Hotlist\",\"Rotulagem bil\u00edngue das informa\u00e7\u00f5es exigidas, incluindo alerg\u00eanicos de fragr\u00e2ncia acima dos limites\"]}},\"tech\":{\"md\":\"O que pode ser aproveitado depende da classe do dispositivo, dos materiais, do tipo e tempo de contato com o corpo, do software e do uso pretendido no novo mercado. Uma aprova\u00e7\u00e3o de outro pa\u00eds normalmente n\u00e3o vale sozinha: nossa equipe confirma cada item pelas regras do destino antes de voc\u00ea contar com ele.\",\"ivd\":\"No Brasil, a classe segue o uso pretendido declarado nas instru\u00e7\u00f5es, n\u00e3o s\u00f3 o analito. Os dados de desempenho precisam cobrir as alega\u00e7\u00f5es, as amostras e os usu\u00e1rios declarados no Brasil. Nossa equipe confirma a classe e as evid\u00eancias antes de preparar qualquer documento.\",\"cos\":\"Cada mercado tem as pr\u00f3prias listas de ingredientes proibidos e restritos e as pr\u00f3prias regras para alega\u00e7\u00f5es. Um produto regular em um mercado pode precisar de ajuste na f\u00f3rmula, no r\u00f3tulo ou nas alega\u00e7\u00f5es em outro. Nossa equipe confere a f\u00f3rmula ingrediente por ingrediente antes de voc\u00ea planejar.\"},\"extra\":{\"reliance\":\"Pela IN 290\/2024, a ANVISA pode considerar uma aprova\u00e7\u00e3o pr\u00e9via do FDA, da Health Canada, da TGA ou do MHLW do Jap\u00e3o para alguns dispositivos e IVD das classes III e IV. A aplica\u00e7\u00e3o depende do produto e da an\u00e1lise da ANVISA; o dossi\u00ea brasileiro completo e, para as classes III e IV, o CBPF da ANVISA continuam obrigat\u00f3rios.\",\"ceToBr\":\"A ANVISA n\u00e3o se baseia na marca\u00e7\u00e3o CE na an\u00e1lise: a submiss\u00e3o brasileira \u00e9 preparada por completo e, para as classes III e IV, um certificado ISO 13485 sozinho n\u00e3o substitui o CBPF da ANVISA.\",\"toEu\":\"Aprova\u00e7\u00f5es estrangeiras n\u00e3o s\u00e3o reconhecidas como tal para a marca\u00e7\u00e3o CE; as evid\u00eancias podem ser aproveitadas.\",\"toUs\":\"Nenhuma aprova\u00e7\u00e3o estrangeira substitui a autoriza\u00e7\u00e3o do FDA quando ela \u00e9 exigida. O FDA pode considerar relat\u00f3rios de auditoria MDSAP no planejamento das inspe\u00e7\u00f5es, mas eles n\u00e3o substituem todas as inspe\u00e7\u00f5es.\",\"toCa\":\"A Health Canada exige certificado MDSAP para licen\u00e7as das classes II\u2013IV.\",\"toUk\":\"A Gr\u00e3-Bretanha aceita hoje dispositivos com marca\u00e7\u00e3o CE; a Irlanda do Norte segue as regras da UE. O governo anunciou a aceita\u00e7\u00e3o de longo prazo: confirmamos na avalia\u00e7\u00e3o como isso se aplica ao seu dispositivo.\",\"toEuUs\":\"A equival\u00eancia pelo MDR normalmente exige mais do que a compara\u00e7\u00e3o com um predicado de 510(k).\"},\"svcLinks\":{\"brh\":\"Detentor do registro no Brasil\",\"clin\":\"Avalia\u00e7\u00e3o cl\u00ednica \u00b7 Brasil\",\"cosreg\":\"Registro e notifica\u00e7\u00e3o de cosm\u00e9ticos\"},\"relLabel\":\"Servi\u00e7os no Brasil\"};\nSR_TX.es = {\"crumbHome\":\"Inicio\",\"crumbCur\":\"Soluciones\",\"eyebrow\":\"Soluciones \u00b7 Brasil, UE, Reino Unido, EE. UU., Canad\u00e1\",\"h1a\":\"Encuentre su ruta \",\"h1b\":\"regulatoria\",\"lead\":\"Responda tres preguntas o vea todo lo que hacemos en cada mercado.\",\"modeGuide\":\"Ori\u00e9nteme\",\"modeAll\":\"Mostrar todo\",\"q1\":\"1 \u00b7 Su producto\",\"q2\":\"2 \u00b7 \u00bfD\u00f3nde est\u00e1 hoy?\",\"q3\":\"3 \u00b7 \u00bfAd\u00f3nde quiere llegar?\",\"yourPath\":\"Su ruta\",\"toolName\":\"Sobel Route\",\"seg\":{\"md\":\"Productos sanitarios\",\"ivd\":\"IVD\",\"cos\":\"Cosm\u00e9ticos\"},\"segShort\":{\"md\":[\"Productos\",\"sanitarios\"],\"ivd\":[\"IVD\"],\"cos\":[\"Cosm\u00e9ticos\"]},\"mk\":{\"br\":\"Brasil\",\"eu\":\"Uni\u00f3n Europea\",\"uk\":\"Reino Unido\",\"us\":\"EE. UU.\",\"ca\":\"Canad\u00e1\"},\"mkShort\":{\"br\":\"Brasil\",\"eu\":\"UE\",\"uk\":\"Reino Unido\",\"us\":\"EE. UU.\",\"ca\":\"Canad\u00e1\"},\"from\":{\"none\":\"A\u00fan no est\u00e1 en el mercado\",\"br\":\"Brasil\",\"eu\":\"Uni\u00f3n Europea (CE)\",\"us\":\"EE. UU. (FDA)\",\"ca\":\"Canad\u00e1\"},\"firstMarket\":\"Primer mercado: \",\"already\":\" ya en el mercado: \",\"reuseLabel\":\"Normalmente reutilizable, con adaptaci\u00f3n\",\"includesLabel\":\"Qu\u00e9 incluye la ruta\",\"alwaysNew\":\"Normalmente nuevo para \",\"nextLabel\":\"Lo que suele venir despu\u00e9s\",\"next\":[\"Cambios, renovaciones y nuevos productos\",\"Vigilancia poscomercializaci\u00f3n (tecno o cosmetovigilancia)\",\"Soporte regulatorio continuo\"],\"techLabel\":\"Confirmaci\u00f3n t\u00e9cnica\",\"cta\":\"Hable con un especialista\",\"open\":\"Abrir \",\"see\":\"Vea c\u00f3mo trabajamos\",\"notOffered\":\"No ofrecido hoy\",\"ivdOnly\":\"Hoy Sobel atiende IVD solo en Brasil. Cu\u00e9ntenos sobre su producto y le sugerimos una ruta.\",\"ask\":\"Cons\u00faltenos sobre este mercado\",\"onRequest\":\"bajo consulta\",\"services\":\" servicios\",\"wheelAria\":\"Rueda de servicios de Sobel: servicios para todos los mercados en el centro, tres segmentos y cinco mercados por segmento\",\"ringText\":\"PARA TODOS LOS SEGMENTOS Y MERCADOS \u00b7 PARA TODOS LOS SEGMENTOS Y MERCADOS \u00b7\",\"oneTeam\":\"Un equipo\",\"legend\":{\"across\":\"Todos los mercados\",\"md\":\"Productos sanitarios\",\"ivd\":\"IVD\",\"cos\":\"Cosm\u00e9ticos\"},\"wheelHint\":\"El anillo dorado re\u00fane servicios para los segmentos y mercados. Pase el cursor o toque cualquier parte para explorar.\",\"acrossEye\":\"Todos los mercados\",\"acrossReg\":\"Productos sanitarios \u00b7 IVD \u00b7 Cosm\u00e9ticos\",\"acrossNote\":\"Disponible para los segmentos y mercados, definido caso por caso.\",\"segEye\":\"Segmento\",\"segReg\":\"Cinco mercados, una estrategia\",\"segNote\":\"Elija un mercado en el anillo exterior para ver sus servicios.\",\"mktNote\":\"Cada servicio se define para su producto, con etapas y responsabilidades acordadas desde el inicio.\",\"askNote\":\"Definimos este mercado caso por caso con nuestro equipo regulatorio.\",\"openMarket\":\"Abrir la p\u00e1gina del mercado\",\"acrossTitle\":\"Para todos los mercados\",\"across\":{\"audits\":{\"t\":\"Auditor\u00edas\",\"d\":\"Auditor\u00edas internas, de proveedores y simulacros de certificaci\u00f3n\",\"items\":[\"Auditor\u00edas internas: ISO 13485, ISO 9001, MDSAP\",\"Auditor\u00edas de proveedores\",\"Simulacros de auditor\u00eda de certificaci\u00f3n\",\"Presencial, remota o h\u00edbrida\"]},\"qs\":{\"t\":\"Sistemas de calidad\",\"d\":\"ISO 13485, MDSAP, FDA QMSR, BPF ANVISA, ISO 22716\",\"items\":[\"ISO 13485 y MDSAP\",\"FDA QMSR\",\"BPF ANVISA (RDC 665\/2022)\",\"ISO 22716 para cosm\u00e9ticos\"]},\"training\":{\"t\":\"Capacitaci\u00f3n\",\"d\":\"Capacitaci\u00f3n in company para equipos regulatorios y de calidad\",\"items\":[\"Capacitaci\u00f3n in company\",\"En l\u00ednea, en vivo\",\"Talleres con sus documentos\"]}},\"reg\":{\"md\":{\"br\":\"ANVISA \u00b7 RDC 751\/2022\",\"eu\":\"MDR (UE) 2017\/745\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"ivd\":{\"br\":\"ANVISA \u00b7 RDC 830\/2023\",\"eu\":\"IVDR (UE) 2017\/746\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"cos\":{\"br\":\"ANVISA \u00b7 RDC 907\/2024\",\"eu\":\"Reglamento (CE) 1223\/2009\",\"uk\":\"UK Cosmetics Regulation\",\"us\":\"FDA \u00b7 MoCRA\",\"ca\":\"Health Canada \u00b7 Cosmetic Regulations\"}},\"sv\":{\"md\":{\"br\":[\"Notificaci\u00f3n o registro ante ANVISA\",\"Titular del registro, a trav\u00e9s de nuestro socio homologado\",\"Evaluaci\u00f3n biol\u00f3gica\",\"Evaluaci\u00f3n cl\u00ednica\",\"Apoyo en ANATEL e INMETRO\"],\"eu\":[\"Apoyo al marcado CE\",\"Apoyo con el Representante Autorizado en la UE\",\"Evaluaci\u00f3n biol\u00f3gica\",\"Evaluaci\u00f3n cl\u00ednica\"],\"uk\":\"ask\",\"us\":[\"Consultor\u00eda regulatoria FDA\",\"Apoyo con el US Agent\",\"Evaluaci\u00f3n biol\u00f3gica\"],\"ca\":[\"Licencia de Health Canada\",\"Evaluaci\u00f3n biol\u00f3gica\"]},\"ivd\":{\"br\":[\"Notificaci\u00f3n o registro de IVD\",\"Titular del registro, a trav\u00e9s de nuestro socio homologado\"],\"eu\":null,\"uk\":null,\"us\":null,\"ca\":null},\"cos\":{\"br\":[\"Notificaci\u00f3n y registro\",\"Titular, a trav\u00e9s de nuestro socio homologado\"],\"eu\":[\"Apoyo en la notificaci\u00f3n CPNP; coordinaci\u00f3n del informe de seguridad\",\"Apoyo con la Persona Responsable en la UE\",\"Product Information File\"],\"uk\":\"ask\",\"us\":[\"Registro y listado MoCRA\",\"Apoyo con el US Agent\",\"Fundamentaci\u00f3n de la seguridad\"],\"ca\":[\"Notificaci\u00f3n de cosm\u00e9ticos\",\"Apoyo en la evaluaci\u00f3n de seguridad\"]}},\"reuse\":{\"md\":[\"Documentaci\u00f3n t\u00e9cnica, adaptada al nuevo formato\",\"Expediente de gesti\u00f3n de riesgos (ISO 14971)\",\"Evaluaci\u00f3n biol\u00f3gica (ISO 10993)\",\"Informes de ensayos de banco, el\u00e9ctricos y de software\",\"Datos cl\u00ednicos, reevaluados seg\u00fan las nuevas reglas\",\"Sistema de calidad ISO 13485 e informes de auditor\u00eda MDSAP, cuando se aceptan\"],\"ivd\":[\"Documentaci\u00f3n t\u00e9cnica\",\"Datos de rendimiento anal\u00edtico y cl\u00ednico\",\"Datos de estabilidad\",\"Expediente de gesti\u00f3n de riesgos (ISO 14971)\",\"Sistema de calidad ISO 13485 e informes de auditor\u00eda MDSAP, cuando se aceptan\"],\"cos\":[\"Datos de la f\u00f3rmula y de los ingredientes (INCI)\",\"Datos y estudios de seguridad\",\"Datos de estabilidad y compatibilidad\",\"Estudios que respaldan sus declaraciones\"]},\"fresh\":{\"md\":{\"br\":[\"Clase seg\u00fan la RDC 751\/2022: notificaci\u00f3n (clases I\u2013II) o registro (clases III\u2013IV)\",\"Titular del registro con AFE, a trav\u00e9s de nuestro socio homologado\",\"Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n de ANVISA (CBPF) para clases III y IV\",\"Etiquetado e instrucciones de uso en portugu\u00e9s\",\"Certificaci\u00f3n INMETRO para equipos el\u00e9ctricos, cuando corresponda\"],\"eu\":[\"Clase seg\u00fan el MDR y, para la mayor\u00eda de las clases, evaluaci\u00f3n por Organismo Notificado\",\"Representante Autorizado en la UE (para fabricantes fuera de la UE) y persona responsable del cumplimiento normativo\",\"Evaluaci\u00f3n cl\u00ednica seg\u00fan el MDR, normalmente con seguimiento cl\u00ednico poscomercializaci\u00f3n\",\"Lista de requisitos de seguridad y funcionamiento, plan e informes de vigilancia poscomercializaci\u00f3n\",\"UDI, registro en EUDAMED y etiquetado en el idioma de cada pa\u00eds\"],\"uk\":[\"UK Responsible Person para fabricantes fuera del Reino Unido\",\"Registro ante la MHRA antes de comercializar en Gran Breta\u00f1a\",\"Marcado CE o UKCA en Gran Breta\u00f1a seg\u00fan las reglas actuales; Irlanda del Norte sigue las reglas de la UE\",\"Vigilancia poscomercializaci\u00f3n seg\u00fan las reglas actuales de Gran Breta\u00f1a\"],\"us\":[\"Clase y v\u00eda, como exento, 510(k), De Novo o PMA\",\"Registro del establecimiento, listado del dispositivo y US Agent para establecimientos extranjeros\",\"Sistema de calidad seg\u00fan el QMSR (21 CFR 820, que incorpora la ISO 13485)\",\"Ensayos espec\u00edficos de la FDA, cuando se requieran, y, para 510(k) o De Novo, presentaci\u00f3n en eSTAR\",\"Etiquetado de EE. UU., UDI cuando aplique y notificaci\u00f3n de eventos adversos\"],\"ca\":[\"Medical Device Licence para clases II\u2013IV; las licencias de establecimiento (MDEL) dependen de la clase y del papel de cada empresa\",\"Certificado MDSAP para solicitudes de licencia de clases II\u2013IV\",\"Etiquetado en ingl\u00e9s o franc\u00e9s; cierta informaci\u00f3n en ambos idiomas para productos vendidos al p\u00fablico\",\"Notificaci\u00f3n obligatoria de problemas\"]},\"ivd\":{\"br\":[\"Clase seg\u00fan el uso previsto, conforme a la RDC 830\/2023: notificaci\u00f3n (clases I\u2013II) o registro (clases III\u2013IV)\",\"Titular del registro con AFE, a trav\u00e9s de nuestro socio homologado\",\"Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n de ANVISA (CBPF) para clases III y IV\",\"Etiquetado e instrucciones en portugu\u00e9s: impresas para algunos usos, como los autotests; en formato electr\u00f3nico en otros casos, bajo condiciones\",\"An\u00e1lisis previo en un laboratorio oficial brasile\u00f1o, cuando se exige para el producto\"]},\"cos\":{\"br\":[\"Empresa brasile\u00f1a con AFE como titular, a trav\u00e9s de nuestro socio homologado\",\"Notificaci\u00f3n previa para la mayor\u00eda de los productos; registro para algunas categor\u00edas, como protectores solares, repelentes, productos para alisar u ondular el cabello, bronceadores y gel antis\u00e9ptico para manos\",\"F\u00f3rmula verificada con las listas de ingredientes de Brasil\",\"Etiquetado en portugu\u00e9s, incluida la lista de ingredientes\"],\"eu\":[\"Persona Responsable en la UE\",\"Notificaci\u00f3n en el CPNP antes de comercializar\",\"Product Information File, que incluye un informe de seguridad firmado por un evaluador de seguridad cualificado\",\"Etiquetado en el idioma que exige cada pa\u00eds; sin ensayos en animales para cumplir los requisitos de cosm\u00e9ticos\"],\"uk\":[\"UK Responsible Person, indicada en la etiqueta\",\"Notificaci\u00f3n en el SCPN para Gran Breta\u00f1a; Irlanda del Norte sigue las reglas de la UE\",\"Product Information File e informe de seguridad disponibles en el Reino Unido\",\"Informaci\u00f3n obligatoria de la etiqueta en ingl\u00e9s\"],\"us\":[\"Registro de la instalaci\u00f3n y listado de productos, salvo exenci\u00f3n\",\"US Agent para instalaciones fuera de EE. UU.\",\"Fundamentaci\u00f3n de la seguridad por la persona responsable\",\"Notificaci\u00f3n de eventos adversos graves y etiquetado de EE. UU.\"],\"ca\":[\"Cosmetic Notification Form tras la primera venta, dentro del plazo previsto\",\"F\u00f3rmula verificada con la Cosmetic Ingredient Hotlist\",\"Etiquetado biling\u00fce de la informaci\u00f3n exigida, incluidos al\u00e9rgenos de fragancia sobre los l\u00edmites\"]}},\"tech\":{\"md\":\"Lo que se puede reutilizar depende de la clase del producto, los materiales, el tipo y la duraci\u00f3n del contacto con el cuerpo, el software y el uso previsto en el nuevo mercado. Una aprobaci\u00f3n de otro pa\u00eds normalmente no vale por s\u00ed sola: nuestro equipo confirma cada punto seg\u00fan las reglas del destino antes de que usted cuente con \u00e9l.\",\"ivd\":\"En Brasil la clase sigue el uso previsto declarado en las instrucciones, no solo el analito. Los datos de rendimiento deben cubrir las declaraciones, las muestras y los usuarios que declare en Brasil. Nuestro equipo confirma la clase y la evidencia antes de preparar cualquier documento.\",\"cos\":\"Cada mercado tiene sus propias listas de ingredientes prohibidos y restringidos y sus propias reglas para las declaraciones. Un producto conforme en un mercado puede requerir cambios en la f\u00f3rmula, la etiqueta o las declaraciones en otro. Nuestro equipo verifica la f\u00f3rmula ingrediente por ingrediente antes de que usted planifique.\"},\"extra\":{\"reliance\":\"Seg\u00fan la IN 290\/2024, ANVISA puede tener en cuenta una aprobaci\u00f3n previa de la FDA, Health Canada, la TGA o el MHLW de Jap\u00f3n para algunos productos sanitarios e IVD de clase III y IV. Su aplicaci\u00f3n depende del producto y de la evaluaci\u00f3n de ANVISA; el expediente brasile\u00f1o completo y, para las clases III y IV, el CBPF de ANVISA siguen siendo obligatorios.\",\"ceToBr\":\"ANVISA no se basa en el marcado CE en su evaluaci\u00f3n: la solicitud brasile\u00f1a se prepara completa y, para las clases III y IV, un certificado ISO 13485 por s\u00ed solo no sustituye el CBPF de ANVISA.\",\"toEu\":\"Las aprobaciones extranjeras no se reconocen como tales para el marcado CE; la evidencia puede reutilizarse.\",\"toUs\":\"Ninguna aprobaci\u00f3n extranjera sustituye la autorizaci\u00f3n de la FDA cuando se exige. La FDA puede tener en cuenta los informes de auditor\u00eda MDSAP al planificar sus inspecciones, pero no sustituyen todas las inspecciones.\",\"toCa\":\"Health Canada exige un certificado MDSAP para las licencias de clases II\u2013IV.\",\"toUk\":\"Gran Breta\u00f1a acepta hoy productos con marcado CE; Irlanda del Norte sigue las reglas de la UE. El gobierno anunci\u00f3 la aceptaci\u00f3n a largo plazo: en la evaluaci\u00f3n confirmamos c\u00f3mo se aplica a su producto.\",\"toEuUs\":\"La equivalencia seg\u00fan el MDR normalmente exige m\u00e1s que la comparaci\u00f3n con un predicado de 510(k).\"},\"svcLinks\":{\"brh\":\"Titular del registro en Brasil\",\"clin\":\"Evaluaci\u00f3n cl\u00ednica \u00b7 Brasil\",\"cosreg\":\"Registro y notificaci\u00f3n de cosm\u00e9ticos\"},\"relLabel\":\"Servicios en Brasil\"};\nSR_TX.de = {\"crumbHome\":\"Startseite\",\"crumbCur\":\"L\u00f6sungen\",\"eyebrow\":\"L\u00f6sungen \u00b7 Brasilien, EU, UK, USA, Kanada\",\"h1a\":\"Finden Sie Ihren regulatorischen \",\"h1b\":\"Weg\",\"lead\":\"Beantworten Sie drei Fragen oder sehen Sie alles, was wir in jedem Markt tun.\",\"modeGuide\":\"F\u00fchren Sie mich\",\"modeAll\":\"Alles anzeigen\",\"q1\":\"1 \u00b7 Ihr Produkt\",\"q2\":\"2 \u00b7 Wo ist es heute?\",\"q3\":\"3 \u00b7 Wohin m\u00f6chten Sie?\",\"yourPath\":\"Ihr Weg\",\"toolName\":\"Sobel Route\",\"seg\":{\"md\":\"Medizinprodukte\",\"ivd\":\"IVD\",\"cos\":\"Kosmetik\"},\"segShort\":{\"md\":[\"Medizin-\",\"produkte\"],\"ivd\":[\"IVD\"],\"cos\":[\"Kosmetik\"]},\"mk\":{\"br\":\"Brasilien\",\"eu\":\"Europ\u00e4ische Union\",\"uk\":\"Vereinigtes K\u00f6nigreich\",\"us\":\"USA\",\"ca\":\"Kanada\"},\"mkShort\":{\"br\":\"Brasilien\",\"eu\":\"EU\",\"uk\":\"UK\",\"us\":\"USA\",\"ca\":\"Kanada\"},\"from\":{\"none\":\"Noch nicht auf dem Markt\",\"br\":\"Brasilien\",\"eu\":\"Europ\u00e4ische Union (CE)\",\"us\":\"USA (FDA)\",\"ca\":\"Kanada\"},\"firstMarket\":\"Erster Markt: \",\"already\":\" bereits auf dem Markt: \",\"reuseLabel\":\"Meist wiederverwendbar, mit Anpassung\",\"includesLabel\":\"Was der Weg umfasst\",\"alwaysNew\":\"Meist neu f\u00fcr \",\"nextLabel\":\"Was \u00fcblicherweise folgt\",\"next\":[\"\u00c4nderungen, Verl\u00e4ngerungen und neue Produkte\",\"\u00dcberwachung nach dem Inverkehrbringen und Vigilanz\",\"Laufende regulatorische Betreuung\"],\"techLabel\":\"Technische Best\u00e4tigung\",\"cta\":\"Expertenrat anfragen\",\"open\":\"\u00d6ffnen: \",\"see\":\"So arbeiten wir\",\"notOffered\":\"Derzeit nicht angeboten\",\"ivdOnly\":\"Derzeit betreut Sobel IVD nur in Brasilien. Erz\u00e4hlen Sie uns von Ihrem Produkt, und wir schlagen einen Weg vor.\",\"ask\":\"Fragen Sie uns zu diesem Markt\",\"onRequest\":\"auf Anfrage\",\"services\":\" Leistungen\",\"wheelAria\":\"Leistungsrad von Sobel: Leistungen f\u00fcr alle M\u00e4rkte in der Mitte, drei Segmente und f\u00fcnf M\u00e4rkte je Segment\",\"ringText\":\"F\u00dcR ALLE SEGMENTE UND M\u00c4RKTE \u00b7 F\u00dcR ALLE SEGMENTE UND M\u00c4RKTE \u00b7\",\"oneTeam\":\"Ein Team\",\"legend\":{\"across\":\"Alle M\u00e4rkte\",\"md\":\"Medizinprodukte\",\"ivd\":\"IVD\",\"cos\":\"Kosmetik\"},\"wheelHint\":\"Der goldene Ring b\u00fcndelt Leistungen f\u00fcr Segmente und M\u00e4rkte. Zeigen oder tippen Sie auf einen Bereich.\",\"acrossEye\":\"Alle M\u00e4rkte\",\"acrossReg\":\"Medizinprodukte \u00b7 IVD \u00b7 Kosmetik\",\"acrossNote\":\"F\u00fcr Segmente und M\u00e4rkte verf\u00fcgbar, im Einzelfall abgestimmt.\",\"segEye\":\"Segment\",\"segReg\":\"F\u00fcnf M\u00e4rkte, eine Strategie\",\"segNote\":\"W\u00e4hlen Sie einen Markt im \u00e4u\u00dferen Ring, um die Leistungen zu sehen.\",\"mktNote\":\"Jede Leistung wird auf Ihr Produkt zugeschnitten, mit von Anfang an vereinbarten Schritten und Verantwortlichkeiten.\",\"askNote\":\"Diesen Markt kl\u00e4ren wir Fall f\u00fcr Fall mit unserem Regulatory-Team.\",\"openMarket\":\"Marktseite \u00f6ffnen\",\"acrossTitle\":\"F\u00fcr alle M\u00e4rkte\",\"across\":{\"audits\":{\"t\":\"Audits\",\"d\":\"Interne Audits, Lieferantenaudits und Probeaudits zur Zertifizierung\",\"items\":[\"Interne Audits: ISO 13485, ISO 9001, MDSAP\",\"Lieferantenaudits\",\"Probeaudits zur Zertifizierung\",\"Vor Ort, remote oder hybrid\"]},\"qs\":{\"t\":\"Qualit\u00e4tsmanagementsysteme\",\"d\":\"ISO 13485, MDSAP, FDA QMSR, ANVISA-GMP, ISO 22716\",\"items\":[\"ISO 13485 und MDSAP\",\"FDA QMSR\",\"ANVISA-GMP (RDC 665\/2022)\",\"ISO 22716 f\u00fcr Kosmetik\"]},\"training\":{\"t\":\"Schulungen\",\"d\":\"Inhouse-Schulungen f\u00fcr Regulatory- und Qualit\u00e4tsteams\",\"items\":[\"Inhouse-Schulungen\",\"Online, live\",\"Workshops mit Ihren Dokumenten\"]}},\"reg\":{\"md\":{\"br\":\"ANVISA \u00b7 RDC 751\/2022\",\"eu\":\"EU-MDR 2017\/745\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"ivd\":{\"br\":\"ANVISA \u00b7 RDC 830\/2023\",\"eu\":\"EU-IVDR 2017\/746\",\"uk\":\"MHRA \u00b7 UK MDR 2002\",\"us\":\"FDA \u00b7 21 CFR\",\"ca\":\"Health Canada \u00b7 SOR\/98-282\"},\"cos\":{\"br\":\"ANVISA \u00b7 RDC 907\/2024\",\"eu\":\"Verordnung (EG) 1223\/2009\",\"uk\":\"UK Cosmetics Regulation\",\"us\":\"FDA \u00b7 MoCRA\",\"ca\":\"Health Canada \u00b7 Cosmetic Regulations\"}},\"sv\":{\"md\":{\"br\":[\"ANVISA-Notifizierung oder -Registrierung\",\"Registrierungsinhaber \u00fcber unseren qualifizierten Partner\",\"Biologische Beurteilung\",\"Klinische Bewertung\",\"Unterst\u00fctzung bei ANATEL und INMETRO\"],\"eu\":[\"Unterst\u00fctzung bei der CE-Kennzeichnung\",\"Unterst\u00fctzung beim EU-Bevollm\u00e4chtigten\",\"Biologische Beurteilung\",\"Klinische Bewertung\"],\"uk\":\"ask\",\"us\":[\"Regulatorische Beratung FDA\",\"Unterst\u00fctzung beim US Agent\",\"Biologische Beurteilung\"],\"ca\":[\"Lizenz bei Health Canada\",\"Biologische Beurteilung\"]},\"ivd\":{\"br\":[\"IVD-Notifizierung oder -Registrierung\",\"Registrierungsinhaber \u00fcber unseren qualifizierten Partner\"],\"eu\":null,\"uk\":null,\"us\":null,\"ca\":null},\"cos\":{\"br\":[\"Notifizierung und Registrierung\",\"Inhaber in Brasilien \u00fcber unseren qualifizierten Partner\"],\"eu\":[\"Unterst\u00fctzung bei der CPNP-Notifizierung; Koordination des Sicherheitsberichts\",\"Unterst\u00fctzung bei der Verantwortlichen Person in der EU\",\"Produktinformationsdatei\"],\"uk\":\"ask\",\"us\":[\"MoCRA-Registrierung und Listung\",\"Unterst\u00fctzung beim US Agent\",\"Sicherheitsnachweis\"],\"ca\":[\"Kosmetik-Notifizierung\",\"Unterst\u00fctzung bei der Sicherheitsbewertung\"]}},\"reuse\":{\"md\":[\"Technische Dokumentation, an das neue Format angepasst\",\"Risikomanagementakte (ISO 14971)\",\"Biologische Beurteilung (ISO 10993)\",\"Pr\u00fcfberichte zu Labor-, elektrischen und Softwaretests\",\"Klinische Daten, nach den neuen Regeln neu bewertet\",\"QMS nach ISO 13485 und MDSAP-Auditberichte, soweit anerkannt\"],\"ivd\":[\"Technische Dokumentation\",\"Daten zur analytischen und klinischen Leistung\",\"Stabilit\u00e4tsdaten\",\"Risikomanagementakte (ISO 14971)\",\"QMS nach ISO 13485 und MDSAP-Auditberichte, soweit anerkannt\"],\"cos\":[\"Rezeptur- und Inhaltsstoffdaten (INCI)\",\"Sicherheitsdaten und Studien\",\"Stabilit\u00e4ts- und Kompatibilit\u00e4tsdaten\",\"Studien zur Belegung Ihrer Werbeaussagen\"]},\"fresh\":{\"md\":{\"br\":[\"Klasse nach RDC 751\/2022: Notifizierung (Klasse I\u2013II) oder Registrierung (Klasse III\u2013IV)\",\"Registrierungsinhaber mit AFE \u00fcber unseren qualifizierten Partner\",\"ANVISA-GMP-Zertifikat (CBPF) f\u00fcr Klasse III und IV\",\"Kennzeichnung und Gebrauchsanweisung auf Portugiesisch\",\"INMETRO-Zertifizierung f\u00fcr elektrische Ger\u00e4te, sofern zutreffend\"],\"eu\":[\"Klasse nach MDR und, f\u00fcr die meisten Klassen, Konformit\u00e4tsbewertung durch eine Benannte Stelle\",\"EU-Bevollm\u00e4chtigter (f\u00fcr Hersteller au\u00dferhalb der EU) und eine f\u00fcr die Einhaltung der Regulierungsvorschriften verantwortliche Person\",\"Klinische Bewertung nach MDR, meist mit klinischer Nachbeobachtung nach dem Inverkehrbringen\",\"Checkliste der grundlegenden Sicherheits- und Leistungsanforderungen, PMS-Plan und -Berichte\",\"UDI, EUDAMED-Registrierung und Kennzeichnung in der Sprache jedes Landes\"],\"uk\":[\"UK Responsible Person f\u00fcr Hersteller au\u00dferhalb des Vereinigten K\u00f6nigreichs\",\"MHRA-Registrierung vor dem Inverkehrbringen in Gro\u00dfbritannien\",\"CE-Kennzeichnung oder UKCA in Gro\u00dfbritannien nach den aktuellen Regeln; Nordirland folgt den EU-Regeln\",\"\u00dcberwachung nach dem Inverkehrbringen nach den aktuellen britischen Regeln\"],\"us\":[\"Produktklasse und Weg, z. B. ausgenommen, 510(k), De Novo oder PMA\",\"Registrierung des Betriebs, Produktlistung und US Agent f\u00fcr ausl\u00e4ndische Betriebe\",\"Qualit\u00e4tsmanagement nach QMSR (21 CFR 820, mit Einbeziehung der ISO 13485)\",\"FDA-spezifische Pr\u00fcfungen, soweit erforderlich, und, bei 510(k) oder De Novo, Einreichung \u00fcber eSTAR\",\"US-Kennzeichnung, UDI soweit zutreffend und Meldung unerw\u00fcnschter Ereignisse\"],\"ca\":[\"Medical Device Licence f\u00fcr Klasse II\u2013IV; Betriebslizenzen (MDEL) h\u00e4ngen von der Klasse und der Rolle jedes Unternehmens ab\",\"MDSAP-Zertifikat f\u00fcr Lizenzantr\u00e4ge der Klasse II\u2013IV\",\"Kennzeichnung auf Englisch oder Franz\u00f6sisch; bestimmte Angaben in beiden Sprachen bei Produkten f\u00fcr Verbraucher\",\"Meldepflicht f\u00fcr Vorkommnisse\"]},\"ivd\":{\"br\":[\"Klasse nach Zweckbestimmung gem\u00e4\u00df RDC 830\/2023: Notifizierung (Klasse I\u2013II) oder Registrierung (Klasse III\u2013IV)\",\"Registrierungsinhaber mit AFE \u00fcber unseren qualifizierten Partner\",\"ANVISA-GMP-Zertifikat (CBPF) f\u00fcr Klasse III und IV\",\"Kennzeichnung und Gebrauchsanweisung auf Portugiesisch: gedruckt f\u00fcr bestimmte Anwendungen wie Eigenanwendung; in anderen F\u00e4llen elektronisch, unter Bedingungen\",\"Vorabanalyse durch ein amtliches brasilianisches Labor, wenn f\u00fcr das Produkt vorgeschrieben\"]},\"cos\":{\"br\":[\"Brasilianisches Unternehmen mit AFE als Inhaber, \u00fcber unseren qualifizierten Partner\",\"Vorab-Notifizierung f\u00fcr die meisten Produkte; Registrierung f\u00fcr bestimmte Kategorien wie Sonnenschutz, Insektenschutz, Produkte zum Gl\u00e4tten oder Wellen der Haare, Br\u00e4unungsprodukte und antiseptisches H\u00e4ndegel\",\"Rezeptur gegen die brasilianischen Inhaltsstofflisten gepr\u00fcft\",\"Kennzeichnung auf Portugiesisch, einschlie\u00dflich der Liste der Inhaltsstoffe\"],\"eu\":[\"Verantwortliche Person in der EU\",\"CPNP-Notifizierung vor dem Inverkehrbringen\",\"Produktinformationsdatei mit einem Sicherheitsbericht, unterzeichnet von einer qualifizierten Person f\u00fcr die Sicherheitsbewertung\",\"Kennzeichnung in der von jedem Land verlangten Sprache; keine Tierversuche zur Erf\u00fcllung der Kosmetikvorschriften\"],\"uk\":[\"UK Responsible Person, auf dem Etikett genannt\",\"SCPN-Notifizierung f\u00fcr Gro\u00dfbritannien; Nordirland folgt den EU-Regeln\",\"Produktinformationsdatei und Sicherheitsbericht im Vereinigten K\u00f6nigreich verf\u00fcgbar\",\"Pflichtangaben auf dem Etikett auf Englisch\"],\"us\":[\"Registrierung der Betriebsst\u00e4tte und Produktlistung, sofern keine Ausnahme gilt\",\"US Agent f\u00fcr Betriebsst\u00e4tten au\u00dferhalb der USA\",\"Sicherheitsnachweis durch die verantwortliche Person\",\"Meldung schwerwiegender unerw\u00fcnschter Ereignisse und US-Kennzeichnung\"],\"ca\":[\"Cosmetic Notification Form nach dem ersten Verkauf, innerhalb der vorgegebenen Frist\",\"Rezeptur gegen die Cosmetic Ingredient Hotlist gepr\u00fcft\",\"Zweisprachige Pflichtangaben, einschlie\u00dflich Duftstoffallergenen \u00fcber den Grenzwerten\"]}},\"tech\":{\"md\":\"Was wiederverwendet werden kann, h\u00e4ngt von Klasse, Materialien, Art und Dauer des K\u00f6rperkontakts, Software und Zweckbestimmung im neuen Markt ab. Eine Zulassung aus einem anderen Land gilt in der Regel nicht automatisch: Unser Team best\u00e4tigt jeden Punkt nach den Regeln des Zielmarkts, bevor Sie damit planen.\",\"ivd\":\"In Brasilien richtet sich die Klasse nach der Zweckbestimmung in Ihrer Gebrauchsanweisung, nicht nur nach dem Analyten. Die Leistungsdaten m\u00fcssen die in Brasilien angegebenen Aussagen, Probenarten und Anwender abdecken. Unser Team best\u00e4tigt Klasse und Nachweise, bevor ein Dokument erstellt wird.\",\"cos\":\"Jeder Markt hat eigene Listen verbotener und eingeschr\u00e4nkter Inhaltsstoffe und eigene Regeln f\u00fcr Werbeaussagen. Ein in einem Markt konformes Produkt kann in einem anderen \u00c4nderungen an Rezeptur, Etikett oder Aussagen ben\u00f6tigen. Unser Team pr\u00fcft die Rezeptur Inhaltsstoff f\u00fcr Inhaltsstoff, bevor Sie planen.\"},\"extra\":{\"reliance\":\"Nach IN 290\/2024 kann ANVISA eine bestehende Zulassung durch FDA, Health Canada, TGA oder das japanische MHLW f\u00fcr einige Medizinprodukte und IVD der Klasse III und IV ber\u00fccksichtigen. Ob das greift, h\u00e4ngt vom Produkt und von der Pr\u00fcfung durch ANVISA ab; das vollst\u00e4ndige brasilianische Dossier und, f\u00fcr Klasse III und IV, das ANVISA-GMP-Zertifikat bleiben erforderlich.\",\"ceToBr\":\"ANVISA st\u00fctzt sich bei der Pr\u00fcfung nicht auf die CE-Kennzeichnung: Die brasilianische Einreichung wird vollst\u00e4ndig erstellt, und f\u00fcr Klasse III und IV ersetzt ein ISO-13485-Zertifikat allein das ANVISA-GMP-Zertifikat nicht.\",\"toEu\":\"Ausl\u00e4ndische Zulassungen werden f\u00fcr die CE-Kennzeichnung nicht als solche anerkannt; Nachweise k\u00f6nnen wiederverwendet werden.\",\"toUs\":\"Keine ausl\u00e4ndische Zulassung ersetzt die FDA-Freigabe oder -Zulassung, wo sie erforderlich ist. Die FDA kann MDSAP-Auditberichte bei der Planung von Inspektionen ber\u00fccksichtigen, sie ersetzen aber nicht alle Inspektionen.\",\"toCa\":\"Health Canada verlangt f\u00fcr Lizenzen der Klasse II\u2013IV ein MDSAP-Zertifikat.\",\"toUk\":\"Gro\u00dfbritannien erkennt CE-gekennzeichnete Produkte derzeit an; Nordirland folgt den EU-Regeln. 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Passe o mouse ou toque em um mercado para ver os servi\u00e7os.',\n  wheelAria: 'Sobel Route: dois pilares para todo produto e mercado no anel dourado, tr\u00eas segmentos e cinco mercados para cada segmento',\n  pillars: { rq: { t: 'Regulat\u00f3rio e Qualidade', items: ['Sistemas da qualidade: ISO 13485, MDSAP e BPF', 'Gerenciamento de risco (ISO 14971)', 'Auditorias internas, de fornecedores e simuladas', 'Treinamentos in company'] },\n   ce: { t: 'Evid\u00eancia Cl\u00ednica e Seguran\u00e7a do Produto', items: ['Biocompatibilidade: avalia\u00e7\u00e3o biol\u00f3gica (ISO 10993)', 'Caracteriza\u00e7\u00e3o qu\u00edmica e avalia\u00e7\u00e3o de risco toxicol\u00f3gico', 'Avalia\u00e7\u00e3o cl\u00ednica para cada mercado'] } } },\n es: { lead2: 'Vea lo que hacemos en cada mercado y arme la ruta de su producto.', jumpAll: 'Lo que hacemos', jumpGuide: 'Arme su ruta',\n  allEye: '1 \u00b7 Lo que hacemos', allTitle: 'Servicios por segmento y mercado',\n  guideEye: '2 \u00b7 Su ruta', guideTitle: 'Arme la ruta de su producto',\n  q1: 'Su producto', q2: 'Lo que usted ya tiene', q3: 'A d\u00f3nde quiere ir',\n  notYet: 'A\u00fan sin aprobaci\u00f3n', haveTitle: 'Lo que usted ya tiene', newTitle: 'Lo que suele ser nuevo para ', newSub: 'Exigido por las reglas del destino',\n  helpTitle: 'Servicios de Sobel para esta ruta', techSum: 'Confirmaci\u00f3n t\u00e9cnica: lo que puede cambiar este resultado', confirm: 'Confirmamos cada punto en su evaluaci\u00f3n.',\n  hint2: 'El anillo dorado muestra lo que aplica a todo producto y mercado. 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'<p class=\"sr-bs\">' + esc(sub) + '<\/p>' : '') + '<ul>' + items.map(function (i) { return '<li>' + esc(i) + '<\/li>'; }).join('') + '<\/ul><\/div>'; }\n  function renderGuide() {\n    chips($('#sr-q1'), SEGK, T.seg, S.seg, 'seg');\n    chips($('#sr-q2'), FRK, T.from, S.from, 'from');\n    chips($('#sr-q3'), MKK, T.mk, S.to, 'to');\n    var seg = S.seg, from = S.from, to = S.to, h = '', reg = T.reg[seg][to], offered = T.sv[seg][to] !== null, V = T.v2;\n    var fromL = from === 'none' ? V.notYet : T.from[from], route = '<span class=\"sr-pill' + (from === 'none' ? ' sr-pill-none' : '') + '\">' + flagSvg(from, 24) + esc(fromL) + '<\/span><span class=\"sr-toarr\" aria-label=\"\u2192\"><svg viewBox=\"0 0 24 24\" width=\"22\" height=\"22\"><path d=\"M4 12h15M13 6l6 6-6 6\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg><\/span><span class=\"sr-pill\">' + flagSvg(to, 24) + esc(T.mk[to]) + '<\/span>';\n    h += '<div class=\"sr-rhead\"><p class=\"sr-route\"><span class=\"sr-rl\">' + esc(T.yourPath) + '<\/span>' + route + '<span class=\"sr-reg\">' + esc(T.seg[seg] + ' \u00b7 ' + (offered ? reg : T.notOffered)) + '<\/span><\/p><\/div>';\n    if (!offered) { h += '<p class=\"sr-p\">' + esc(T.ivdOnly) + '<\/p><div class=\"sr-actions\"><a class=\"sr-btn\" href=\"' + CTA + '\">' + esc(T.cta) + '<\/a><\/div>'; $('#sr-res').innerHTML = h; return; }\n    var boxes = '';\n    if (from === to) boxes = box('sr-new sr-wide', IPL, T.nextLabel, '', T.next);\n    else if (from === 'none') boxes = box('sr-new sr-wide', IPL, T.includesLabel, V.newSub, T.fresh[seg][to]);\n    else boxes = box('sr-have', ICK, V.haveTitle, T.reuseLabel, T.reuse[seg]) + box('sr-new', IPL, V.newTitle + T.mk[to], V.newSub, T.fresh[seg][to]);\n    h += '<div class=\"sr-rgrid\">' + boxes + '<div class=\"sr-side\">';\n    var tiles = [], ml = mkLink(seg, to);\n    if (to === 'br' && REL[seg] && T.svcLinks) REL[seg].forEach(function (k) { var u = svcLink(k); if (u) tiles.push('<a class=\"sr-tile\" href=\"' + u + '\"><span>' + esc(T.svcLinks[k]) + '<\/span><i aria-hidden=\"true\">\u2192<\/i><\/a>'); });\n    if (ml) tiles.push('<a class=\"sr-tile\" href=\"' + ml + '\"><span>' + esc(T.seg[seg] + ' \u00b7 ' + T.mk[to]) + '<\/span><i aria-hidden=\"true\">\u2192<\/i><\/a>');\n    if (tiles.length) h += '<div class=\"sr-help\"><p class=\"sr-bt2\">' + esc(V.helpTitle) + '<\/p><div class=\"sr-tiles\">' + tiles.join('') + '<\/div><\/div>';\n    if (from !== to && from !== 'none') { var ex = extraNote(seg, from, to); h += '<details class=\"sr-techd\"><summary>' + IIN + '<span>' + esc(V.techSum) + '<\/span><\/summary><p>' + esc(T.tech[seg]) + '<\/p>' + ex.map(function (t) { return '<p>' + esc(t) + '<\/p>'; }).join('') + '<\/details>'; }\n    h += '<div class=\"sr-actions\"><a class=\"sr-btn\" href=\"' + CTA + '\">' + esc(T.cta) + '<\/a><span class=\"sr-confirm\">' + esc(V.confirm) + '<\/span><\/div><\/div><\/div>';\n    $('#sr-res').innerHTML = h;\n  }\n\n  var P = function (r, a) { var t = (a - 90) * Math.PI \/ 180; return [300 + r * Math.cos(t), 300 + r * Math.sin(t)]; };\n  var arc = function (r0, r1, a0, a1) { var Lg = (a1 - a0) > 180 ? 1 : 0, p0 = P(r1, a0), p1 = P(r1, a1), p2 = P(r0, a1), p3 = P(r0, a0); return 'M' + p0[0].toFixed(1) + ' ' + p0[1].toFixed(1) + 'A' + r1 + ' ' + r1 + ' 0 ' + Lg + ' 1 ' + p1[0].toFixed(1) + ' ' + p1[1].toFixed(1) + 'L' + p2[0].toFixed(1) + ' ' + p2[1].toFixed(1) + 'A' + r0 + ' ' + r0 + ' 0 ' + Lg + ' 0 ' + p3[0].toFixed(1) + ' ' + p3[1].toFixed(1) + 'Z'; };\n  var R = function (x, y, w, hh) { return 'M' + x.toFixed(1) + ' ' + y.toFixed(1) + 'h' + w.toFixed(1) + 'v' + hh.toFixed(1) + 'h' + (-w).toFixed(1) + 'Z'; };\n  var C = function (x, y, r) { return 'M' + (x - r).toFixed(1) + ' ' + y.toFixed(1) + 'a' + r + ' ' + r + ' 0 1 0 ' + (2 * r) + ' 0a' + r + ' ' + r + ' 0 1 0 ' + (-2 * r) + ' 0Z'; };\n  var FLAG = function (mk, cx, cy, o) { var x = cx - 15, y = cy - 10, out = []; var add = function (d, c) { out.push({ d: d, f: c, o: o }); };\n    if (mk === 'br') { add(R(x, y, 30, 20), '#229E45'); add('M' + (cx - 12) + ' ' + cy + 'L' + cx + ' ' + (cy - 8) + 'L' + (cx + 12) + ' ' + cy + 'L' + cx + ' ' + (cy + 8) + 'Z', '#F8E509'); add(C(cx, cy, 4.5), '#2B49A3'); }\n    if (mk === 'eu') { add(R(x, y, 30, 20), '#003399'); for (var i = 0; i < 12; i++) { var t = i * Math.PI \/ 6; add(C(cx + 6 * Math.cos(t), cy + 6 * Math.sin(t), 1.1), '#FFCC00'); } }\n    if (mk === 'uk') { add(R(x, y, 30, 20), '#012169'); add('M' + x + ' ' + y + 'L' + (x + 4) + ' ' + y + 'L' + (x + 30) + ' ' + (y + 17) + 'L' + (x + 30) + ' ' + (y + 20) + 'L' + (x + 26) + ' ' + (y + 20) + 'L' + x + ' ' + (y + 3) + 'Z', '#FFFFFF'); add('M' + (x + 30) + ' ' + y + 'L' + (x + 30) + ' ' + (y + 3) + 'L' + (x + 4) + ' ' + (y + 20) + 'L' + x + ' ' + (y + 20) + 'L' + x + ' ' + (y + 17) + 'L' + (x + 26) + ' ' + y + 'Z', '#FFFFFF'); add(R(cx - 4, y, 8, 20), '#FFFFFF'); add(R(x, cy - 4, 30, 8), '#FFFFFF'); add(R(cx - 2.2, y, 4.4, 20), '#C8102E'); add(R(x, cy - 2.2, 30, 4.4), '#C8102E'); }\n    if (mk === 'us') { for (var j = 0; j < 7; j++) add(R(x, y + j * 20 \/ 7, 30, 20 \/ 7), j % 2 ? '#FFFFFF' : '#B22234'); add(R(x, y, 13, 20 * 4 \/ 7), '#3C3B6E'); }\n    if (mk === 'ca') { add(R(x, y, 30, 20), '#FFFFFF'); add(R(x, y, 7.5, 20), '#D80621'); add(R(x + 22.5, y, 7.5, 20), '#D80621'); add('M' + cx + ' ' + (cy - 6) + 'L' + (cx + 2) + ' ' + (cy - 2) + 'L' + (cx + 5) + ' ' + (cy - 3) + 'L' + (cx + 3) + ' ' + (cy + 2) + 'L' + (cx + 1) + ' ' + (cy + 2) + 'L' + (cx + 1) + ' ' + (cy + 6) + 'L' + (cx - 1) + ' ' + (cy + 6) + 'L' + (cx - 1) + ' ' + (cy + 2) + 'L' + (cx - 3) + ' ' + (cy + 2) + 'L' + (cx - 5) + ' ' + (cy - 3) + 'L' + (cx - 2) + ' ' + (cy - 2) + 'Z', '#D80621'); }\n    add(R(x, y, 30, 0.8), 'rgba(5,27,90,0.15)'); add(R(x, y + 19.2, 30, 0.8), 'rgba(5,27,90,0.15)'); return out; };\n  var ICON = function (sk, x, y, col) { if (sk === 'md') return [{ d: 'M' + x + ' ' + (y + 8) + 'C' + (x - 13) + ' ' + y + ' ' + (x - 10) + ' ' + (y - 11) + ' ' + x + ' ' + (y - 4) + 'C' + (x + 10) + ' ' + (y - 11) + ' ' + (x + 13) + ' ' + y + ' ' + x + ' ' + (y + 8) + 'Z', f: col, s: 'none', w: 0 }, { d: 'M' + (x - 9) + ' ' + (y - 1) + 'h4l2 -4l3 7l2 -3h6', f: 'none', s: '#FFFFFF', w: 1.6 }];\n    if (sk === 'ivd') return [{ d: 'M' + (x - 3.5) + ' ' + (y - 10) + 'v15a3.5 3.5 0 0 0 7 0v-15', f: 'none', s: col, w: 2 }, { d: 'M' + (x - 6) + ' ' + (y - 10) + 'h12', f: 'none', s: col, w: 2 }, { d: 'M' + (x - 3.5) + ' ' + (y - 1) + 'h7v6a3.5 3.5 0 0 1 -7 0Z', f: col, s: 'none', w: 0 }, { d: C(x + 8, y - 6, 1.6) + C(x + 10, y - 12, 1.1), f: col, s: 'none', w: 0 }];\n    return [{ d: 'M' + (x - 3) + ' ' + (y - 12) + 'h6v4h-6Z', f: col, s: 'none', w: 0 }, { d: 'M' + (x - 1) + ' ' + (y - 15) + 'h2v3h-2Z', f: col, s: 'none', w: 0 }, { d: 'M' + (x - 7) + ' ' + (y - 8) + 'h14v13a3 3 0 0 1 -3 3h-8a3 3 0 0 1 -3 -3Z', f: col, s: 'none', w: 0 }, { d: 'M' + (x - 3.5) + ' ' + (y - 1) + 'h7', f: 'none', s: '#FFFFFF', w: 1.6 }]; };\n  var AICON = function (id, ix, iy, col) { if (id === 'audits') return [{ d: 'M' + (ix - 6) + ' ' + (iy - 7) + 'h12v15h-12Z', f: 'none', s: col, w: 1.8 }, { d: 'M' + (ix - 3) + ' ' + (iy - 9) + 'h6v3.5h-6Z', f: col, s: 'none', w: 0 }, { d: 'M' + (ix - 3) + ' ' + (iy + 1) + 'l2 2l4 -4', f: 'none', s: col, w: 1.8 }];\n    if (id === 'qs') return [{ d: 'M' + ix + ' ' + (iy - 8) + 'l7 3v5c0 4 -3 7 -7 8c-4 -1 -7 -4 -7 -8v-5Z', f: col, s: 'none', w: 0 }, { d: 'M' + (ix - 3) + ' ' + iy + 'l2 2l4 -4', f: 'none', s: '#FFFFFF', w: 1.8 }];\n    return [{ d: 'M' + (ix - 9) + ' ' + (iy - 2) + 'l9 -5l9 5l-9 5Z', f: col, s: 'none', w: 0 }, { d: 'M' + (ix - 5) + ' ' + (iy + 1) + 'v4c0 2.5 10 2.5 10 0v-4', f: 'none', s: col, w: 1.8 }, { d: 'M' + (ix + 8) + ' ' + (iy - 1) + 'v5', f: 'none', s: col, w: 1.6 }]; };\n  var SEGC = { md: '#2A72C8', ivd: '#149189', cos: '#9471CF' }, SEGD = { md: '#174A8C', ivd: '#0B5F5A', cos: '#5E3F98' }, SEGT = { md: '#E3EEFB', ivd: '#DDF3F1', cos: '#F1EAFB' };\n  var ACRK = ['audits', 'qs', 'training'], AMID = { audits: 60, qs: 180, training: 300 };\n  var LOGO = window.SR_LOGO || '';\n\n  function svCount(v) { return Array.isArray(v) ? v.length + T.services : (v === null ? '\u2014' : T.onRequest); }\n\n  var S_LOGO = '<g transform=\"translate(268 262.4) scale(0.8)\" aria-hidden=\"true\"><path d=\"M39 0h2v1h-2ZM37 1h6v1h-6ZM36 2h8v1h-8ZM34 3h12v1h-12ZM32 4h16v1h-16ZM31 5h19v1h-19ZM29 6h22v1h-22ZM27 7h26v1h-26ZM25 8h30v1h-30ZM24 9h32v1h-32ZM22 10h36v1h-36ZM20 11h40v1h-40ZM19 12h43v1h-43ZM17 13h46v1h-46ZM15 14h24v1h-24ZM42 14h23v1h-23ZM14 15h23v1h-23ZM43 15h24v1h-24ZM12 16h23v1h-23ZM45 16h23v1h-23ZM10 17h24v1h-24ZM47 17h23v1h-23ZM8 18h24v1h-24ZM48 18h24v1h-24ZM7 19h23v1h-23ZM50 19h24v1h-24ZM5 20h24v1h-24ZM52 20h23v1h-23ZM3 21h24v1h-24ZM53 21h24v1h-24ZM2 22h23v1h-23ZM55 22h24v1h-24ZM0 23h23v1h-23ZM57 23h23v1h-23ZM0 24h22v1h-22ZM58 24h22v1h-22ZM0 25h20v1h-20ZM60 25h20v1h-20ZM0 26h18v1h-18ZM62 26h18v1h-18ZM0 27h16v1h-16ZM39 27h3v1h-3ZM64 27h16v1h-16ZM0 28h15v1h-15ZM37 28h6v1h-6ZM65 28h15v1h-15ZM0 29h13v1h-13ZM35 29h10v1h-10ZM67 29h13v1h-13ZM0 30h12v1h-12ZM33 30h14v1h-14ZM68 30h12v1h-12ZM0 31h12v1h-12ZM32 31h16v1h-16ZM68 31h12v1h-12ZM0 32h12v1h-12ZM30 32h20v1h-20ZM68 32h12v1h-12ZM0 33h12v1h-12ZM29 33h23v1h-23ZM68 33h12v1h-12ZM0 34h12v1h-12ZM31 34h22v1h-22ZM68 34h12v1h-12ZM0 35h12v1h-12ZM33 35h22v1h-22ZM69 35h11v1h-11ZM0 36h12v1h-12ZM35 36h22v1h-22ZM70 36h10v1h-10ZM0 37h12v1h-12ZM36 37h22v1h-22ZM71 37h9v1h-9ZM0 38h14v1h-14ZM38 38h22v1h-22ZM73 38h7v1h-7ZM0 39h16v1h-16ZM40 39h22v1h-22ZM75 39h5v1h-5ZM0 40h18v1h-18ZM41 40h23v1h-23ZM77 40h3v1h-3ZM0 41h19v1h-19ZM43 41h22v1h-22ZM78 41h2v1h-2ZM0 42h21v1h-21ZM45 42h22v1h-22ZM1 43h22v1h-22ZM47 43h22v1h-22ZM2 44h22v1h-22ZM48 44h22v1h-22ZM4 45h22v1h-22ZM50 45h22v1h-22ZM6 46h22v1h-22ZM52 46h22v1h-22ZM8 47h22v1h-22ZM54 47h22v1h-22ZM9 48h22v1h-22ZM55 48h22v1h-22ZM11 49h22v1h-22ZM57 49h22v1h-22ZM13 50h22v1h-22ZM58 50h22v1h-22ZM0 51h2v1h-2ZM15 51h21v1h-21ZM60 51h20v1h-20ZM0 52h4v1h-4ZM16 52h22v1h-22ZM62 52h18v1h-18ZM0 53h6v1h-6ZM18 53h22v1h-22ZM64 53h16v1h-16ZM0 54h8v1h-8ZM20 54h22v1h-22ZM65 54h15v1h-15ZM0 55h9v1h-9ZM22 55h21v1h-21ZM67 55h13v1h-13ZM0 56h11v1h-11ZM23 56h22v1h-22ZM68 56h12v1h-12ZM0 57h12v1h-12ZM25 57h22v1h-22ZM68 57h12v1h-12ZM0 58h12v1h-12ZM27 58h22v1h-22ZM68 58h12v1h-12ZM0 59h12v1h-12ZM28 59h22v1h-22ZM68 59h12v1h-12ZM0 60h12v1h-12ZM30 60h20v1h-20ZM68 60h12v1h-12ZM0 61h12v1h-12ZM32 61h17v1h-17ZM68 61h12v1h-12ZM0 62h12v1h-12ZM34 62h13v1h-13ZM68 62h12v1h-12ZM0 63h12v1h-12ZM35 63h10v1h-10ZM68 63h12v1h-12ZM0 64h13v1h-13ZM37 64h6v1h-6ZM67 64h13v1h-13ZM0 65h15v1h-15ZM39 65h3v1h-3ZM65 65h15v1h-15ZM0 66h16v1h-16ZM64 66h16v1h-16ZM0 67h18v1h-18ZM62 67h18v1h-18ZM0 68h20v1h-20ZM60 68h20v1h-20ZM0 69h22v1h-22ZM58 69h22v1h-22ZM0 70h23v1h-23ZM57 70h23v1h-23ZM2 71h23v1h-23ZM55 71h24v1h-24ZM3 72h24v1h-24ZM53 72h24v1h-24ZM5 73h24v1h-24ZM52 73h23v1h-23ZM7 74h23v1h-23ZM50 74h24v1h-24ZM8 75h24v1h-24ZM48 75h24v1h-24ZM10 76h24v1h-24ZM47 76h23v1h-23ZM12 77h23v1h-23ZM45 77h23v1h-23ZM14 78h23v1h-23ZM43 78h24v1h-24ZM15 79h24v1h-24ZM42 79h23v1h-23ZM17 80h46v1h-46ZM19 81h43v1h-43ZM20 82h40v1h-40ZM22 83h36v1h-36ZM24 84h32v1h-32ZM25 85h30v1h-30ZM27 86h26v1h-26ZM29 87h22v1h-22ZM31 88h19v1h-19ZM32 89h16v1h-16ZM34 90h12v1h-12ZM36 91h8v1h-8ZM37 92h6v1h-6ZM39 93h2v1h-2Z\" fill=\"#FFFFFF\"><\/path><\/g>';\n  var SEGM = { md: '#A9C7EC', ivd: '#A6DAD5', cos: '#CDBDEB' }, SEGL = { md: '#D3E3F7', ivd: '#CDEBE8', cos: '#E6DDF6' };\n  function FLAG2(mk, cx, cy, o, mono) { var u = 1.1, out = [], first = true;\n    var Pt = function (a, b) { return (cx + (a - 15) * u).toFixed(1) + ' ' + (cy + (b - 10) * u).toFixed(1); };\n    var Rr = function (a, b, w, h) { return 'M' + Pt(a, b) + 'L' + Pt(a + w, b) + 'L' + Pt(a + w, b + h) + 'L' + Pt(a, b + h) + 'Z'; };\n    var Cc = function (a, b, r) { return C(cx + (a - 15) * u, cy + (b - 10) * u, r * u); };\n    var add = function (d, c) { if (mono) { out.push({ d: d, f: first ? mono[0] : mono[1], o: first ? o : o * 0.7, fl: 'none' }); first = false; } else out.push({ d: d, f: c, o: o, fl: 'none' }); };\n    out.push({ d: Rr(0, 0, 30, 20), f: '#FFFFFF', o: 1, fl: 'url(#srFlagShadow)' });\n    if (mk === 'br') { add(Rr(0, 0, 30, 20), '#229E45'); add('M' + Pt(3, 10) + 'L' + Pt(15, 2) + 'L' + Pt(27, 10) + 'L' + Pt(15, 18) + 'Z', '#F8E509'); add(Cc(15, 10, 4.5), '#2B49A3'); }\n    if (mk === 'eu') { add(Rr(0, 0, 30, 20), '#003399'); for (var i = 0; i < 12; i++) { var t = i * Math.PI \/ 6; add(Cc(15 + 6.5 * Math.cos(t), 10 + 6.5 * Math.sin(t), 1.4), '#FFCC00'); } }\n    if (mk === 'uk') { add(Rr(0, 0, 30, 20), '#012169'); add('M' + Pt(0, 0) + 'L' + Pt(4, 0) + 'L' + Pt(30, 17) + 'L' + Pt(30, 20) + 'L' + Pt(26, 20) + 'L' + Pt(0, 3) + 'Z', '#FFFFFF'); add('M' + Pt(30, 0) + 'L' + Pt(30, 3) + 'L' + Pt(4, 20) + 'L' + Pt(0, 20) + 'L' + Pt(0, 17) + 'L' + Pt(26, 0) + 'Z', '#FFFFFF'); add(Rr(11, 0, 8, 20), '#FFFFFF'); add(Rr(0, 6, 30, 8), '#FFFFFF'); add(Rr(12.8, 0, 4.4, 20), '#C8102E'); add(Rr(0, 7.8, 30, 4.4), '#C8102E'); }\n    if (mk === 'us') { for (var j = 0; j < 7; j++) add(Rr(0, j * 20 \/ 7, 30, 20 \/ 7), j % 2 ? '#FFFFFF' : '#B22234'); add(Rr(0, 0, 13, 20 * 4 \/ 7), '#3C3B6E'); }\n    if (mk === 'ca') { add(Rr(0, 0, 30, 20), '#FFFFFF'); add(Rr(0, 0, 7.5, 20), '#D80621'); add(Rr(22.5, 0, 7.5, 20), '#D80621'); add('M' + [[15, 4], [17, 8], [20, 7], [18, 12], [16, 12], [16, 16], [14, 16], [14, 12], [12, 12], [10, 7], [13, 8]].map(function (q) { return Pt(q[0], q[1]); }).join('L') + 'Z', '#D80621'); }\n    return out; }\n  function ICON2(sk, x, y, col, inner, k) { var X = function (d) { return (x + d * k).toFixed(1); }, Y = function (d) { return (y + d * k).toFixed(1); }, L = function (d) { return (d * k).toFixed(1); };\n    if (sk === 'md') return [{ d: 'M' + X(0) + ' ' + Y(8) + 'C' + X(-13) + ' ' + Y(0) + ' ' + X(-10) + ' ' + Y(-11) + ' ' + X(0) + ' ' + Y(-4) + 'C' + X(10) + ' ' + Y(-11) + ' ' + X(13) + ' ' + Y(0) + ' ' + X(0) + ' ' + Y(8) + 'Z', f: col, s: 'none', w: 0 }, { d: 'M' + X(-6.5) + ' ' + Y(0.5) + 'h' + L(3) + 'l' + L(1.5) + ' ' + L(-3) + 'l' + L(2.5) + ' ' + L(6) + 'l' + L(1.5) + ' ' + L(-3) + 'h' + L(4), f: 'none', s: inner, w: 1.5 * k }];\n    if (sk === 'ivd') return [{ d: 'M' + X(-4) + ' ' + Y(-11) + 'v' + L(16) + 'a' + L(4) + ' ' + L(4) + ' 0 0 0 ' + L(8) + ' 0v' + L(-16), f: 'none', s: col, w: 2.2 * k }, { d: 'M' + X(-6.5) + ' ' + Y(-11) + 'h' + L(13), f: 'none', s: col, w: 2.2 * k }, { d: 'M' + X(-4) + ' ' + Y(-1) + 'h' + L(8) + 'v' + L(6) + 'a' + L(4) + ' ' + L(4) + ' 0 0 1 ' + L(-8) + ' 0Z', f: col, s: 'none', w: 0 }];\n    return [{ d: 'M' + X(-6) + ' ' + Y(3) + 'h' + L(12) + 'v' + L(9) + 'a' + L(1.5) + ' ' + L(1.5) + ' 0 0 1 ' + L(-1.5) + ' ' + L(1.5) + 'h' + L(-9) + 'a' + L(1.5) + ' ' + L(1.5) + ' 0 0 1 ' + L(-1.5) + ' ' + L(-1.5) + 'Z', f: col, s: 'none', w: 0 }, { d: 'M' + X(-4.5) + ' ' + Y(-1) + 'h' + L(9) + 'v' + L(3.5) + 'h' + L(-9) + 'Z', f: col, s: 'none', w: 0 }, { d: 'M' + X(-3.5) + ' ' + Y(-1.5) + 'v' + L(-8) + 'l' + L(7) + ' ' + L(-4) + 'v' + L(12) + 'Z', f: col, s: 'none', w: 0 }, { d: 'M' + X(-6) + ' ' + Y(7) + 'h' + L(12), f: 'none', s: inner, w: 1.4 * k }]; }\n  var arcS = function (r0, r1, a0, a1) { var p0 = P(r1, a0), p1 = P(r1, a1), p2 = P(r0, a1), p3 = P(r0, a0); return 'M' + p0[0].toFixed(1) + ' ' + p0[1].toFixed(1) + 'A' + r1 + ' ' + r1 + ' 0 0 1 ' + p1[0].toFixed(1) + ' ' + p1[1].toFixed(1) + 'L' + p2[0].toFixed(1) + ' ' + p2[1].toFixed(1) + 'A' + r0 + ' ' + r0 + ' 0 0 0 ' + p3[0].toFixed(1) + ' ' + p3[1].toFixed(1) + 'Z'; };\n  function renderWheel() {\n    var SEL = S.wsel, V = T.v2, all = SEL.type === 'pillar', seg = (SEL.type === 'seg' || SEL.type === 'mkt') ? SEL.seg : null;\n    var W = [], I = [], F = [], Lb = [];\n    ['rq', 'ce'].forEach(function (pk, i) { var on = all && SEL.id === pk; W.push({ d: arcS(70, 116, i === 0 ? -90 : 90, i === 0 ? 90 : 270), fill: on ? '#F2B705' : (all ? '#F9DA7A' : '#FDF0CE'), op: 1, sel: 'p:' + pk, label: V.pillars[pk].t }); });\n    SEGK.forEach(function (sk, i) { var a0 = i * 120, segSel = SEL.type === 'seg' && seg === sk, inF = seg === sk, lit = all || inF;\n      W.push({ d: arcS(120, 180, a0, a0 + 120), fill: segSel ? SEGD[sk] : (lit ? SEGC[sk] : SEGT[sk]), op: 1, sel: 's:' + sk, label: T.seg[sk] });\n      var c = P(150, a0 + 60), k = sk === 'md' ? 1.75 : 1.5;\n      ICON2(sk, c[0], c[1], lit ? '#FFFFFF' : SEGC[sk], lit ? (segSel ? SEGD[sk] : SEGC[sk]) : SEGT[sk], k).forEach(function (ic) { ic.o = lit ? 1 : 0.6; I.push(ic); });\n      MKK.forEach(function (mk, j) { var b0 = a0 + j * 24, off = T.sv[sk][mk] === null, sel = SEL.type === 'mkt' && SEL.seg === sk && SEL.mkt === mk, hl = all || (inF && !off);\n        W.push({ d: arcS(184, 270, b0, b0 + 24), fill: sel ? SEGD[sk] : (hl ? SEGM[sk] : SEGT[sk]), op: off ? 0.4 : 1, sel: 'm:' + sk + ':' + mk, label: T.seg[sk] + ', ' + T.mk[mk] });\n        var am = b0 + 12, fp = P(228, am);\n        FLAG2(mk, fp[0], fp[1], off ? 0.25 : (sel ? 1 : (hl ? 0.85 : 0.75)), sel ? null : (hl ? [SEGT[sk], SEGM[sk]] : [SEGL[sk], SEGM[sk]])).forEach(function (f) { F.push(f); });\n        var la = am * Math.PI \/ 180, sx = Math.sin(la), sy = -Math.cos(la), lp = P(279, am);\n        Lb.push({ x: lp[0], y: lp[1], ta: sx > 0.3 ? 'start' : (sx < -0.3 ? 'end' : 'middle'), db: sy < -0.3 ? 'text-after-edge' : (sy > 0.3 ? 'text-before-edge' : 'central'), t: T.mkShort[mk], fill: SEGD[sk], op: off ? 0.3 : (sel ? 1 : 0.72), w: sel ? 700 : 600 }); }); });\n    var s = '<svg viewBox=\"-70 -30 740 660\" role=\"img\" aria-label=\"' + esc(V.wheelAria) + '\" class=\"sr-wheel\"><defs><filter id=\"srFlagShadow\" x=\"-40%\" y=\"-50%\" width=\"180%\" height=\"210%\"><feDropShadow dx=\"0\" dy=\"0\" stdDeviation=\"1.8\" flood-color=\"#FFFFFF\" flood-opacity=\"0.95\" result=\"glow\"><\/feDropShadow><feDropShadow in=\"glow\" dx=\"0\" dy=\"1.5\" stdDeviation=\"2.2\" flood-color=\"#051B5A\" flood-opacity=\"0.14\"><\/feDropShadow><\/filter><path id=\"srPillTop\" d=\"M207 300A93 93 0 0 1 393 300\"><\/path><path id=\"srPillBot\" d=\"M207 300A93 93 0 0 0 393 300\"><\/path><\/defs>';\n    W.forEach(function (w) { s += '<path d=\"' + w.d + '\" fill=\"' + w.fill + '\" stroke=\"#FFFFFF\" stroke-width=\"3\" opacity=\"' + w.op + '\" class=\"sr-w\" tabindex=\"0\" role=\"button\" aria-label=\"' + esc(w.label) + '\" data-sel=\"' + w.sel + '\"><\/path>'; });\n    I.forEach(function (ic) { s += '<path d=\"' + ic.d + '\" fill=\"' + ic.f + '\" stroke=\"' + ic.s + '\" stroke-width=\"' + ic.w + '\" stroke-linecap=\"round\" stroke-linejoin=\"round\" opacity=\"' + ic.o + '\" pointer-events=\"none\"><\/path>'; });\n    F.forEach(function (f) { s += '<path d=\"' + f.d + '\" fill=\"' + f.f + '\" opacity=\"' + f.o + '\" filter=\"' + f.fl + '\" pointer-events=\"none\"><\/path>'; });\n    Lb.forEach(function (l) { s += '<text x=\"' + l.x.toFixed(1) + '\" y=\"' + l.y.toFixed(1) + '\" text-anchor=\"' + l.ta + '\" dominant-baseline=\"' + l.db + '\" font-family=\"Host Grotesk, system-ui, sans-serif\" font-size=\"14\" font-weight=\"' + l.w + '\" fill=\"' + l.fill + '\" opacity=\"' + l.op + '\" pointer-events=\"none\">' + esc(l.t) + '<\/text>'; });\n    ['rq', 'ce'].forEach(function (pk, i) { var t = V.pillars[pk].t, on = all && SEL.id === pk, long = t.length > 30; s += '<text font-family=\"Host Grotesk, system-ui, sans-serif\" font-size=\"' + (long ? 12.5 : 14) + '\" font-weight=\"600\" letter-spacing=\"' + (long ? 0.2 : 0.6) + '\" fill=\"' + (on ? 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