{"id":8627,"date":"2020-12-04T11:27:03","date_gmt":"2020-12-04T11:27:03","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8627"},"modified":"2020-12-14T13:18:53","modified_gmt":"2020-12-14T13:18:53","slug":"medical-device-freelancers-how-can-remote-experts-help","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-freelancers-how-can-remote-experts-help\/","title":{"rendered":"Freelancers de Dispositivos M\u00e9dicos: Como os Especialistas Remotos podem ajudar?"},"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-69f64eed4571b\" 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-69f64eed4571b\"><\/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\/medical-device-freelancers-how-can-remote-experts-help\/#1_Regulatory_writing\" title=\"1. Escrita regulamentar\">1. Escrita regulamentar<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-freelancers-how-can-remote-experts-help\/#2_Verification_of_materials_for_new_PPE_or_equipment\" title=\"2. Verifica\u00e7\u00e3o de materiais para novos EPIs ou equipamentos\">2. Verifica\u00e7\u00e3o de materiais para novos EPIs ou equipamentos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-freelancers-how-can-remote-experts-help\/#3_Statistical_verification_for_clinical_trials\" title=\"3. Verifica\u00e7\u00e3o estat\u00edstica para ensaios cl\u00ednicos\">3. Verifica\u00e7\u00e3o estat\u00edstica para ensaios cl\u00ednicos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-freelancers-how-can-remote-experts-help\/#4_Literature_searches\" title=\"4. Pesquisas bibliogr\u00e1ficas\">4. Pesquisas bibliogr\u00e1ficas<\/a><\/li><\/ul><\/nav><\/div>\n<p>\u00c0 medida que a revolu\u00e7\u00e3o freelance toma conta do mundo, aqui est\u00e1 uma vis\u00e3o de como contratar <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">aut\u00f4nomos de dispositivos m\u00e9dicos<\/a> pode ajud\u00e1-lo a crescer r\u00e1pida e facilmente.<\/p>\n<p>A Oval Medical Technologies, uma empresa especializada na entrega de medicamentos, \u00e9 apenas um exemplo de uma empresa m\u00e9dica que se desloca para o trabalho remoto. A empresa anunciou que iria minimizar o n\u00famero de funcion\u00e1rios em laborat\u00f3rios e manter todos os funcion\u00e1rios trabalhando de casa sempre que poss\u00edvel.<\/p>\n<p>Em vista da pandemia, as empresas de dispositivos m\u00e9dicos podem achar mais dif\u00edcil acessar as habilidades especializadas necess\u00e1rias para obter as marcas CE para os produtos atuais, ou trazer novos produtos para o mercado. Uma maneira de acessar habilidades especializadas durante a pandemia \u00e9 consultar um profissional liberal experiente em dispositivos m\u00e9dicos, que pode trabalhar remotamente em projetos regulat\u00f3rios, de ensaios cl\u00ednicos ou estat\u00edsticos. Como os consultores de produtos m\u00e9dicos podem ajudar remotamente?<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Regulatory_writing\"><\/span>1. Escrita regulamentar<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Os fabricantes que ainda n\u00e3o possuem uma marca CE para seus produtos sob os regulamentos de produtos m\u00e9dicos (MDR) devem obter uma para que possam vender o dispositivo na UE uma vez que a transi\u00e7\u00e3o da atual diretiva de produtos m\u00e9dicos (MDD) termine em 2021.<\/p>\n<p>Da mesma forma, aqueles que trazem novos produtos ao mercado para enfrentar a pandemia precisar\u00e3o de acesso r\u00e1pido a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">consultores em assuntos regulat\u00f3rios<\/a> Um freelancer pode ajudar a completar a documenta\u00e7\u00e3o no arquivo t\u00e9cnico, como os relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica (CER), para os quais o MDR agora requer muito mais detalhes.<\/p>\n<p>As empresas de dispositivos m\u00e9dicos podem procurar um freelancer com experi\u00eancia em gerenciamento de projetos cl\u00ednicos, reda\u00e7\u00e3o t\u00e9cnica e com um amplo conhecimento do cen\u00e1rio regulat\u00f3rio, para ajudar nesta tarefa.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Verification_of_materials_for_new_PPE_or_equipment\"><\/span>2. Verifica\u00e7\u00e3o de materiais para novos EPIs ou equipamentos<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A pandemia da COVID-19 provocou uma escassez de m\u00e1scaras e vestidos e muitas institui\u00e7\u00f5es est\u00e3o tendo que reutilizar equipamentos. As empresas est\u00e3o entrando em a\u00e7\u00e3o para ajudar, por exemplo, o fabricante de t\u00eaxteis t\u00e9cnicos Milliken &amp; Company est\u00e1 agora produzindo tecidos de prote\u00e7\u00e3o de barreira cr\u00edtica para vestidos e coberturas de cabe\u00e7a.<\/p>\n<p>Antes que o pessoal do hospital possa utilizar o equipamento, estes novos projetos precisam ser verificados e os materiais verificados quanto \u00e0 seguran\u00e7a e efic\u00e1cia.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Statistical_verification_for_clinical_trials\"><\/span><span style=\"font-size: 18px;\">3. Verifica\u00e7\u00e3o estat\u00edstica para ensaios cl\u00ednicos<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Para obter a marca CE sob a MDR, os fabricantes de produtos existentes podem ter que realizar testes cl\u00ednicos adicionais. Os fabricantes de novos produtos que foram projetados para contribuir para o esfor\u00e7o da COVID-19, tamb\u00e9m podem estar sob press\u00e3o para que os ensaios sejam conclu\u00eddos rapidamente.<\/p>\n<p>A realiza\u00e7\u00e3o de an\u00e1lises estat\u00edsticas de dados de ensaios cl\u00ednicos longe do laborat\u00f3rio pode ser um desafio porque os fabricantes podem n\u00e3o ter o poder computacional e o software necess\u00e1rio quando trabalham a partir de casa.<\/p>\n<p>Uma forma de contornar este desafio \u00e9 recrutar um <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">bioestat\u00edstico remoto<\/a> ou especialista similar habilitado no gerenciamento de dados para realizar tarefas como a compila\u00e7\u00e3o de fichas de dados ou a escrita de algoritmos para seu estudo cl\u00ednico. Como resultado, voc\u00ea pode ficar por dentro de seus dados e monitorar os efeitos de seus dispositivos.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Literature_searches\"><\/span>4. Pesquisas bibliogr\u00e1ficas<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Another vital part of a product\u2019s technical documentation is the literature search. The literature search involves gathering and appraising clinical data from a range of sources, including information from <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> papers or a medical database, such as MEDLINE.<\/p>\n<p>Tamb\u00e9m pode incluir informa\u00e7\u00f5es da concorr\u00eancia, por exemplo, se o fabricante estiver tentando reivindicar equival\u00eancia.<\/p>\n<p>Um freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/literature-search\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">consultor de pesquisa de literatura<\/a> \u00e9 capaz de executar todas as etapas. Usando um protocolo padronizado, eles tamb\u00e9m podem repetir essas buscas atrav\u00e9s de atualiza\u00e7\u00f5es subseq\u00fcentes de CER. Como as RCEs n\u00e3o ser\u00e3o mais um documento est\u00e1tico sob o MDR e ter\u00e3o que ser atualizadas periodicamente, esta \u00e9 uma abordagem voltada para o futuro.<\/p>\n<p>Embora trabalhar em casa seja agora \"uma necessidade\" para muitos fabricantes de dispositivos m\u00e9dicos, n\u00e3o tem que ser uma barreira.<\/p>\n<p><strong>Pronto para contratar <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">aut\u00f4nomos de dispositivos m\u00e9dicos<\/a>? Publique seu projeto no Kolabtree gratuitamente e receba cita\u00e7\u00f5es de especialistas. <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">POSTAR UM PROJETO AGORA<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>As the freelance revolution takes over the world, here&#8217;s a look at how hiring medical device freelancers can help you grow quickly and easily. Oval Medical Technologies, a company that specialises in drug delivery, is just one example of a medical business moving to remote working. The company announced it would minimise the number of<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-freelancers-how-can-remote-experts-help\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":8636,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540,653],"tags":[],"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>Medical Device Freelancers: How Can Remote Experts Help?<\/title>\n<meta name=\"description\" content=\"From regulatory affairs consultants to medical writers, here&#039;s how medical device freelancers can help you, independent of location.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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