{"id":6539,"date":"2019-12-09T05:42:45","date_gmt":"2019-12-09T05:42:45","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6539"},"modified":"2020-03-17T08:14:56","modified_gmt":"2020-03-17T08:14:56","slug":"how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/","title":{"rendered":"Como contratar um redator de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica para seu dispositivo m\u00e9dico"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f42ecb0f4fe\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f42ecb0f4fe\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#1_Experienced_in_implementing_the_new_EU_regulations\" title=\"1. Experi\u00eancia na implementa\u00e7\u00e3o dos novos regulamentos da UE\">1. Experi\u00eancia na implementa\u00e7\u00e3o dos novos regulamentos da UE<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#A_Clinical_Evaluation_Report_writer_compiles_the_CER_using_the_below_guidance_documents\" title=\"Um redator de Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica compila o CER usando os documentos de orienta\u00e7\u00e3o abaixo:\">Um redator de Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica compila o CER usando os documentos de orienta\u00e7\u00e3o abaixo:<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#2_Effective_industry_insider\" title=\"2. Informa\u00e7\u00f5es privilegiadas da ind\u00fastria\">2. Informa\u00e7\u00f5es privilegiadas da ind\u00fastria<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#3_Well-versed_with_scientific_literature\" title=\"3. Bem versado em literatura cient\u00edfica\">3. Bem versado em literatura cient\u00edfica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#4_Familiar_with_the_Economic_Operators_Regime\" title=\"4. Familiarizados com o Regime dos Operadores Econ\u00f4micos\">4. Familiarizados com o Regime dos Operadores Econ\u00f4micos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#5_Strong_analytical_and_report_writing_skills\" title=\"5. Fortes habilidades anal\u00edticas e de reda\u00e7\u00e3o de relat\u00f3rios\">5. Fortes habilidades anal\u00edticas e de reda\u00e7\u00e3o de relat\u00f3rios<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#6_Experience_with_regulatory_affairs_RA\" title=\"6. Experi\u00eancia com assuntos regulat\u00f3rios (RA)\">6. Experi\u00eancia com assuntos regulat\u00f3rios (RA)<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Mahasweta Pal, escritor m\u00e9dico freelance em Kolabtree, escreve sobre as habilidades essenciais que as empresas de dispositivos m\u00e9dicos devem procurar em um<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\"> Redator do Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica<\/a>.\u00a0<\/em><\/p>\n<p>A Dra. Gillian Pritchard, um distinto membro da Associa\u00e7\u00e3o Europ\u00e9ia de Escritores M\u00e9dicos diz que \"a avalia\u00e7\u00e3o cl\u00ednica \u00e9 um procedimento estruturado e cont\u00ednuo para coletar, avaliar e analisar dados cl\u00ednicos relativos a um dispositivo m\u00e9dico\". Estes dados cl\u00ednicos ap\u00f3iam a validade das aplica\u00e7\u00f5es do dispositivo enquanto incluem dados das investiga\u00e7\u00f5es pr\u00e9-cl\u00ednicas e cl\u00ednicas, gerenciamento de risco, vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o e as instru\u00e7\u00f5es de uso.<\/p>\n<p>Continuando a partir de nosso artigo anterior sobre <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-a-clinical-evaluation-report\/\">Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica<\/a>Damos uma olhada nas principais habilidades que os melhores escritores de CER devem ter e que os tornam o adequado para seu projeto.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Experienced_in_implementing_the_new_EU_regulations\"><\/span>1. Experi\u00eancia na implementa\u00e7\u00e3o dos novos regulamentos da UE<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Em particular, para Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica em conformidade com o MDR da UE, os redatores regulamentares precisam estar cientes das melhorias em rela\u00e7\u00e3o \u00e0s diretrizes de relat\u00f3rios anteriores com respeito \u00e0 an\u00e1lise de investiga\u00e7\u00f5es cl\u00ednicas, bem como de documentos de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o. Os especialistas do CER s\u00e3o contratados com base em sua experi\u00eancia para compreender os meandros da fabrica\u00e7\u00e3o de dispositivos m\u00e9dicos, avalia\u00e7\u00f5es internas de seguran\u00e7a e dados de controle de qualidade. Al\u00e9m disso, os redatores do CER devem ser capazes de tratar de quest\u00f5es sobre seguran\u00e7a de dispositivos m\u00e9dicos, qualidade de projeto, certifica\u00e7\u00f5es de fabrica\u00e7\u00e3o, instru\u00e7\u00f5es de uso do fabricante e outros requisitos de conformidade relevantes.<\/p>\n<p>A Uni\u00e3o Europ\u00e9ia publicou o <a href=\"https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations_en\">novos regulamentos de dispositivos m\u00e9dicos<\/a> em abril de 2017. Com rela\u00e7\u00e3o ao MEDDEV 2.7\/1 Rev. 4, um protocolo de avalia\u00e7\u00e3o cl\u00ednica em 5 etapas deve ser seguido por redatores de CER para permitir o processamento e a entrega sem problemas de um CER.<\/p>\n<ul>\n<li><strong>Etapa 0 - Escopo e Plano para o Novo CER<\/strong><\/li>\n<li><strong>Etapa 1 - Coleta de dados relevantes de fontes m\u00faltiplas (estudos de literatura, documentos cl\u00ednicos, registros do fabricante, documentos Premarket, etc.)<\/strong><\/li>\n<li><strong>Etapa 2 - Avalia\u00e7\u00e3o e An\u00e1lise dos Dados Coletados<\/strong><\/li>\n<li><strong>Etapa 3 - An\u00e1lise da Concorr\u00eancia, An\u00e1lise de Equival\u00eancia<\/strong><\/li>\n<li><strong>Etapa 4 - Atualiza\u00e7\u00e3o de CER com dados de Vigil\u00e2ncia P\u00f3s-Mercado (PMS) &amp; Dados de Acompanhamento Cl\u00ednico P\u00f3s-Mercado (PMCF)<\/strong><\/li>\n<\/ul>\n<p>Mais importante ainda, de acordo com as novas diretrizes, os escritores precisam prestar aten\u00e7\u00e3o especial \u00e0s exig\u00eancias de \"evid\u00eancia cl\u00ednica suficiente\", o que significa que as oportunidades, riscos e desafios associados ao ciclo de vida de desenvolvimento cl\u00ednico de um dispositivo m\u00e9dico precisam ser apresentados para serem compat\u00edveis com o MDR da UE.<\/p>\n<h5><span class=\"ez-toc-section\" id=\"A_Clinical_Evaluation_Report_writer_compiles_the_CER_using_the_below_guidance_documents\"><\/span>Um redator de Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica compila o CER usando os documentos de orienta\u00e7\u00e3o abaixo:<span class=\"ez-toc-section-end\"><\/span><\/h5>\n<ul>\n<li><strong>MEDDEV 2.7\/1 Rev. 4 Anexo 1 (publicado em junho de 2016, implementa\u00e7\u00e3o em maio de 2020, referente \u00e0 Avalia\u00e7\u00e3o de Seguran\u00e7a e Desempenho)<\/strong><\/li>\n<li><strong>EN ISO 14155:2011 (Investiga\u00e7\u00e3o Cl\u00ednica de Dispositivos M\u00e9dicos para Sujeitos Humanos e GCP)<\/strong><\/li>\n<li><strong>EN ISO 14971:2012 (Aplica\u00e7\u00e3o cl\u00ednica da gest\u00e3o de riscos a dispositivos m\u00e9dicos)<\/strong><\/li>\n<li><strong>MEDDEV 2.12\/2 rev2 Post Market Clinical Follow-up - Um guia para fabricantes e Organismos Notificados (janeiro de 2012; a ser substitu\u00eddo pelo MDR Anexo XIV).<\/strong><\/li>\n<li><strong>NB Med 2.12 Rec1 - Post Marketing Surveillance (Fevereiro de 2000; A ser substitu\u00eddo pelo MDR Anexo III).<\/strong><\/li>\n<\/ul>\n<p>Dependendo do tipo de dispositivo m\u00e9dico, os redatores de CER podem ter que usar o Software de Quantifica\u00e7\u00e3o e Classifica\u00e7\u00e3o MEDDEV 2.1\/6. No caso de dispositivos mais antigos cujos CERs devem ser atualizados de acordo com o MDR da UE, os dados de teste de usabilidade dos relat\u00f3rios de investiga\u00e7\u00e3o cl\u00ednica devem ser relatados junto com as especifica\u00e7\u00f5es de projeto do dispositivo. Uma grande exig\u00eancia para os redatores de CERs \u00e9 analisar todas as CERs anteriores do dispositivo m\u00e9dico selecionado, estudos comparativos com os dispositivos concorrentes, realizar an\u00e1lises de lacunas e estabelecer o potencial de desempenho do mercado de dispositivos m\u00e9dicos novos.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Effective_industry_insider\"><\/span>2. Informa\u00e7\u00f5es privilegiadas da ind\u00fastria<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>When CER Specialists are industry veterans, their expertise in medical device approvals eases the regulatory journey for manufacturers. A qualified CER expert with a background in Clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">Pesquisa<\/a> Methodology across all therapeutic areas is the manufacturer&#8217;s bigwig. An established CER specialist would be a strong networker privy to regulatory meetings. In light of EU\u2019s complex regulatory landscape, the need of the hour is to select CER specialists with experience of dealing with the multitude of regulatory challenges. They would also be best fit for device manufacturers treading into crowded therapeutic areas, e.g., Cardiology, Endocrinology, Oncology, etc.<\/p>\n<p>Os especialistas do CER devem ser representantes regulares de suas empresas em confer\u00eancias de Regulamenta\u00e7\u00e3o e Conformidade, reuni\u00f5es globais e semin\u00e1rios que discutam os desafios dos regulamentos de seguran\u00e7a de dispositivos m\u00e9dicos. Nas organiza\u00e7\u00f5es de produtos m\u00e9dicos, muitas vezes os redatores do CER t\u00eam que apresentar o CER ao painel de regulamenta\u00e7\u00e3o. Os fabricantes de Produtos m\u00e9dicos tamb\u00e9m exigem que os redatores do CER tenham uma reputa\u00e7\u00e3o positiva em rela\u00e7\u00e3o \u00e0s reuni\u00f5es com os \u00d3rg\u00e3os Notificados, o que torna a apresenta\u00e7\u00e3o e revis\u00e3o do CER uma navega\u00e7\u00e3o tranq\u00fcila. Nesses casos, devem ser escolhidos redatores de CER que tenham habilidades de comunica\u00e7\u00e3o impec\u00e1veis. Os redatores de RCEs que trabalham efetivamente com base em metas de conclus\u00e3o de projetos em etapas seriam preferidos para que as fun\u00e7\u00f5es de triagem e avalia\u00e7\u00e3o de dados ocorram em conjunto com a prepara\u00e7\u00e3o das RCEs. Com efeito, um redator de relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica deve orientar a equipe de controle de qualidade de tal forma que o fabricante do dispositivo m\u00e9dico atinja suas metas regulat\u00f3rias com perda insignificante de tempo.<\/p>\n<p>Fabricantes de dispositivos m\u00e9dicos <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">contratar escritores de CER<\/a> que t\u00eam um cronograma p\u00f3s-entrega para cada um de seus projetos para que os redatores do CER possam fornecer relat\u00f3rios de \"atualiza\u00e7\u00e3o ativa\" com base no perfil de risco do dispositivo. Um redator de RCEs experiente deve rotineiramente realizar revis\u00f5es de literatura, verificar documentos de orienta\u00e7\u00e3o regulat\u00f3ria, participar de reuni\u00f5es de regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos e desenvolver maneiras mais inteligentes de processar RCEs sem qualquer perda de informa\u00e7\u00e3o. medida que as exig\u00eancias de dados cl\u00ednicos da UE se expandiram, um redator de CER que implemente estrat\u00e9gias efetivas de avalia\u00e7\u00e3o cl\u00ednica analisando as diretrizes combinadas MDR &amp; MEDDEV seria a escolha a longo prazo.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Well-versed_with_scientific_literature\"><\/span>3. Bem versado em literatura cient\u00edfica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>O MDR da UE exige que as RCEs sejam avaliadas usando dados sobre dispositivos equivalentes ou similares, e atualiza\u00e7\u00f5es de rotina sobre pesquisa observacional, cl\u00ednica e experimental usando dispositivos m\u00e9dicos. O protocolo de revis\u00e3o de literatura seguido pelos especialistas europeus em RCEs consiste em busca objetiva, n\u00e3o tendenciosa e sistem\u00e1tica, e revis\u00f5es sobre as caracter\u00edsticas do paciente, tipo de interven\u00e7\u00e3o, controle e consultas de resultados. Os redatores do CER precisam estudar documentos cl\u00ednicos e discutir com as equipes multifuncionais que trabalham na an\u00e1lise de risco, aplicando protocolos de gerenciamento de risco, e abrindo as equipes de pesquisa e desenvolvimento de acordo com diferentes insights dos estudos da literatura.<\/p>\n<p>Pesquisas de literatura, meta-an\u00e1lises e coleta de evid\u00eancias cl\u00ednicas envolvem uma infinidade de habilidades de leitura e an\u00e1lise, e espera-se que os escritores do CER dominem todas elas. Portanto, os redatores do CER devem ser leitores eficazes da literatura m\u00e9dica que possam racionalizar os processos de triagem de dados relevantes. S\u00e3o preferidos os redatores de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica experientes com experi\u00eancia na abordagem de lacunas nas evid\u00eancias cl\u00ednicas, dados de eventos adversos e consultas relevantes sobre avalia\u00e7\u00f5es pr\u00e9-cl\u00ednicas e pr\u00e9-comercializa\u00e7\u00e3o.<\/p>\n<p>Os fabricantes tamb\u00e9m precisam de seus redatores de CER para verter em relat\u00f3rios cient\u00edficos e cl\u00ednicos revisados por pares que mostrem evid\u00eancias da funcionalidade do dispositivo e, posteriormente, preparar relat\u00f3rios apresentando os dados de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o. <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Escritores profissionais do CER<\/a> tamb\u00e9m s\u00e3o habilitados em pesquisas de literatura espec\u00edfica em todas as bases de dados de literatura cient\u00edfica de renome mundial. A busca eficiente de dados envolve a navega\u00e7\u00e3o no MEDLINE, Index Medicus, EMBASE\/Excerpta Medica e o Banco de Dados Cochrane de Revis\u00f5es Sistem\u00e1ticas. As principais estrat\u00e9gias de busca utilizadas pelos redatores do CER impulsionam a qualidade do relat\u00f3rio.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Familiar_with_the_Economic_Operators_Regime\"><\/span>4. Familiarizados com o Regime dos Operadores Econ\u00f4micos<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>O MDR da UE cont\u00e9m um regime adicional com respeito aos operadores econ\u00f4micos (EO), que envolve comunica\u00e7\u00e3o com os consultores jur\u00eddicos antes da marca\u00e7\u00e3o CE. O regime EO \u00e9 baseado na regulamenta\u00e7\u00e3o anterior - 765\/2008, que detalha um modelo regulat\u00f3rio para a legisla\u00e7\u00e3o da Uni\u00e3o Europ\u00e9ia (UE) relativa aos dispositivos m\u00e9dicos, levando em conta os conceitos no funcionamento do sistema de marca\u00e7\u00e3o CE, e todos os conceitos relativos aos operadores econ\u00f4micos, tais como o conceito central de 'coloca\u00e7\u00e3o no mercado', 'disponibiliza\u00e7\u00e3o', bem como os operadores econ\u00f4micos na cadeia de fornecimento de produtos e suas obriga\u00e7\u00f5es.<\/p>\n<p>Al\u00e9m disso, o MDR e o IVDR definem explicitamente os requisitos estabelecidos para Fabricantes, Representantes Autorizados, Importadores e Distribuidores (MAID). O <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2019\/10\/implementation-of-shared-mdr-economic-operator-res\">paradigma MAID<\/a> \u00e9 uma atualiza\u00e7\u00e3o sobre as diretrizes anteriores da MEDDEV, detalhando as obriga\u00e7\u00f5es dos fabricantes de reinterpretar sua cadeia de fornecimento e apresentar claramente ao Organismo Notificado o entendimento do papel de cada pessoa na cadeia de fornecimento de dispositivos m\u00e9dicos. De acordo com o Guia Azul (um documento de orienta\u00e7\u00e3o emitido pela Comiss\u00e3o Europ\u00e9ia), \"Cada papel do MAID \u00e9 definido no MDR e IVDR juntamente com conceitos cruciais de 'coloca\u00e7\u00e3o no mercado' e 'disponibiliza\u00e7\u00e3o'. Estes conceitos s\u00e3o determinantes para as responsabilidades regulamentares impostas pelo MDR e pelo IVDR aos diversos EOs na cadeia de fornecimento de dispositivos m\u00e9dicos\".<\/p>\n<p>Um redator de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica deve ter alguma exposi\u00e7\u00e3o ao liderar conversas com especialistas legais que lidam com as obriga\u00e7\u00f5es do regime EO, e ao fornecer os documentos relevantes do lado do fabricante, bem como os documentos de orienta\u00e7\u00e3o pertinentes publicados para cada circunst\u00e2ncia encontrada na jornada de aprova\u00e7\u00e3o do produto. Os fabricantes procuram especialistas em CER que possam analisar e interpretar se e quando um produto deve estar em conformidade com o regime RoHS { de acordo com o <a href=\"https:\/\/ec.europa.eu\/environment\/waste\/rohs_eee\/legis_en.htm\">Restri\u00e7\u00e3o de Subst\u00e2ncias Perigosas Diretiva RoHS (2011\/65\/EC)<\/a>} ou em conformidade com uma nova norma revista (por exemplo, quando a 4\u00aa edi\u00e7\u00e3o do <a href=\"https:\/\/www.medicaldesignbriefs.com\/component\/content\/article\/mdb\/features\/articles\/33060\">Padr\u00e3o para Equipamento El\u00e9trico M\u00e9dico (ME), IEC\/EN 60601-1-2:2018<\/a> tornou-se obrigat\u00f3rio para produtos m\u00e9dicos el\u00e9tricos colocados no mercado a partir de 30 de dezembro de 2018).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Strong_analytical_and_report_writing_skills\"><\/span>5. Fortes habilidades anal\u00edticas e de reda\u00e7\u00e3o de relat\u00f3rios<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Os redatores do CER tamb\u00e9m s\u00e3o as pessoas de contato do fabricante para documentos anteriores com a marca CE desde que as novas diretrizes MDR mudaram a base para a classifica\u00e7\u00e3o dos dispositivos. Assim, os CER <a href=\"https:\/\/www.kolabtree.com\/services\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">escritores m\u00e9dicos<\/a> tamb\u00e9m s\u00e3o contratados por fabricantes de dispositivos m\u00e9dicos para fornecer relat\u00f3rios referentes \u00e0 reclassifica\u00e7\u00e3o de dispositivos e seus processos atualizados de marketing e distribui\u00e7\u00e3o.<\/p>\n<p>Al\u00e9m disso, uma vez que a avalia\u00e7\u00e3o cl\u00ednica envolve a triagem de dados cl\u00ednicos em etapas e a atualiza\u00e7\u00e3o de dados de relat\u00f3rios de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o, os redatores do CER devem ter experi\u00eancia em an\u00e1lise de dados cl\u00ednicos. O redator ideal de CER deve ter entregue pelo menos 50 CERs abrangendo todas as principais \u00e1reas terap\u00eauticas e estar apto a preparar os CERs para todos os tipos de dispositivos m\u00e9dicos.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Experience_with_regulatory_affairs_RA\"><\/span>6. Experi\u00eancia com assuntos regulat\u00f3rios (RA)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>N\u00e3o \u00e9 poss\u00edvel entregar Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica sem ser um especialista comprovado em assuntos regulat\u00f3rios. Os redatores do CER devem ser qualificados na implementa\u00e7\u00e3o das mudan\u00e7as, atualiza\u00e7\u00f5es e melhorias dos sistemas regulat\u00f3rios (tais como o <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/MEMO_17_848\">Comiss\u00e3o Europ\u00e9ia<\/a>, <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/medical-device-regulation_online-guide.html\">Swissmedic<\/a>, <a href=\"https:\/\/www.ansm.sante.fr\/Activites\/Surveillance-du-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMDIV\/Dispositifs-medicaux-Operations-d-evaluation-et-de-controle-du-marche\/(offset)\/3#dm\">ANSM<\/a>etc.) em seus produtos. Essencialmente, um redator de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica deve ser um especialista em assuntos regulat\u00f3rios. Com o aumento das exig\u00eancias de documenta\u00e7\u00e3o, o escopo dos redatores de CER continua se diversificando. Espera-se que os redatores de CER informem os fabricantes quando seus produtos podem ter um CER clinicamente isento (no caso de metodologias equivalentes de fabrica\u00e7\u00e3o e fornecimento, pesquisa de literatura similar e exig\u00eancias de relat\u00f3rios, conforme listado no MEDDEV 2.7\/1 Rev 4).<\/p>\n<p>Todos os arquivos CER devem fornecer informa\u00e7\u00f5es expl\u00edcitas sobre o projeto do dispositivo, caracter\u00edsticas e informa\u00e7\u00f5es sobre o uso previsto, avisos, contra-indica\u00e7\u00f5es, dados de gerenciamento de risco e as fontes de dados. As exig\u00eancias da UE MDR envolvem a implementa\u00e7\u00e3o contratual e orientada por QMS de recursos de operadores econ\u00f4micos compartilhados, UDI e conformidade de rotulagem, coleta de dados de acompanhamento cl\u00ednico p\u00f3s-comercializa\u00e7\u00e3o, e as conseq\u00fc\u00eancias da mudan\u00e7a Brexit e menos Organismos Notificados.<\/p>\n<p><strong>Necessidade de contratar um <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">redator freelance CER<\/a>? Consultar especialistas qualificados em Kolabtree. Publique seu projeto e receba or\u00e7amentos de gra\u00e7a.<\/p>\n<p><\/strong><\/p>\n<p>Peritos relacionados:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Consultores de Produtos m\u00e9dicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Escritor M\u00e9dico Freelancer<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Escritor aut\u00f4nomo do CER<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Consultores MDR da UE<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Envios da FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Especialistas em Pesquisa de Literatura<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Peritos em Conformidade Regulat\u00f3ria<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Especialista em ensaios cl\u00ednicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Escritores Reguladores<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Consultores PMS<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">Consultores da PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">\u00a0Especialistas em Bioestat\u00edstica<\/a> |<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\"> Especialista em desenvolvimento de produtos\u00a0<\/a><\/strong><\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p>Refer\u00eancias:<\/p>\n<ol>\n<li><a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2019\/9\/challenges-in-clinical-evaluation-for-the-eu-versu\">Hunter J e Yan M. \"Desafios na avalia\u00e7\u00e3o cl\u00ednica para a UE contra a China\". Foco Regulat\u00f3rio. Setembro de 2019. Sociedade de Profissionais de Assuntos Regulat\u00f3rios<\/a>.<\/li>\n<li><a href=\"http:\/\/www.imdrf.org\/docs\/ghtf\/final\/sg5\/technical-docs\/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf\">Grupo de Estudo 5: \"Avalia\u00e7\u00e3o Cl\u00ednica - Documento Final\". Maio de 2007. SG5\/N2R8 For\u00e7a Tarefa de Harmoniza\u00e7\u00e3o Global.<\/a><\/li>\n<li><a href=\"https:\/\/journal.emwa.org\/medical-devices\/clinical-evaluation-reports-from-the-medical-writer-s-perspective\/\">Gillian Pritchard. \"Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica do ponto de vista do escritor m\u00e9dico\"!  Journal of Medical Writing; Volume 26, Edi\u00e7\u00e3o 2 - Dispositivos M\u00e9dicos. Junho de 2017. Associa\u00e7\u00e3o Europ\u00e9ia de Escritores M\u00e9dicos<\/a>.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Mahasweta Pal, freelance medical writer on Kolabtree, writes about the essential skills medical device companies should look for in a Clinical Evaluation Report writer.\u00a0 Dr. Gillian Pritchard, a distinguished member of the European Medical Writers&#8217; Association says that &#8220;Clinical evaluation is a structured ongoing procedure to collect, appraise and analyze clinical data pertaining to a<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":32,"featured_media":6567,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,443,540,319,435],"tags":[498,499,474,482],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to hire a Clinical Evaluation Report writer for your Medical Device<\/title>\n<meta name=\"description\" content=\"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. Read up on top skills you should look for in a CER writer.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Hire a Clinical Evaluation Report writer for your medical device\" \/>\n<meta property=\"og:description\" content=\"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. Read up on top skills you should look for in a CER writer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2019-12-09T05:42:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-03-17T08:14:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/12\/hire-a-clinical-evaluation-report-writer.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mahasweta Pal\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mahasweta Pal\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to hire a Clinical Evaluation Report writer for your Medical Device","description":"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. 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Read up on top skills you should look for in a CER writer.","og_url":"https:\/\/www.kolabtree.com\/blog\/pt\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2019-12-09T05:42:45+00:00","article_modified_time":"2020-03-17T08:14:56+00:00","og_image":[{"width":1000,"height":667,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/12\/hire-a-clinical-evaluation-report-writer.jpg","type":"image\/jpeg"}],"author":"Mahasweta Pal","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"Escrito por":"Mahasweta Pal","Est. tempo de leitura":"9 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/"},"author":{"name":"Mahasweta Pal","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/9e27a382e95318cf10b7fe808f31d913"},"headline":"How to Hire a Clinical Evaluation Report writer for your medical device","datePublished":"2019-12-09T05:42:45+00:00","dateModified":"2020-03-17T08:14:56+00:00","mainEntityOfPage":{"@id":"https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/"},"wordCount":1847,"commentCount":0,"publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"keywords":["CER","Clinical Evaluation Report","medical device","medical writer"],"articleSection":["Business support","Healthcare","Medical Devices","Projects","Research"],"inLanguage":"pt-BR","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/","url":"https:\/\/www.kolabtree.com\/blog\/it\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/","name":"How to hire a Clinical Evaluation Report writer for your Medical Device","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/#website"},"datePublished":"2019-12-09T05:42:45+00:00","dateModified":"2020-03-17T08:14:56+00:00","description":"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. 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She majored in Biomedical Engineering from Vellore Institute of Technology and has served as an editor for journal publications from Elsevier, Wolters Kluwer Health and the Royal Society for Chemistry.","url":"https:\/\/www.kolabtree.com\/blog\/pt\/author\/mahasweta-pal\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/posts\/6539"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/comments?post=6539"}],"version-history":[{"count":19,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/posts\/6539\/revisions"}],"predecessor-version":[{"id":7233,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/posts\/6539\/revisions\/7233"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/media\/6567"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/media?parent=6539"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/categories?post=6539"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/pt\/wp-json\/wp\/v2\/tags?post=6539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}