{"id":8325,"date":"2020-09-10T10:56:04","date_gmt":"2020-09-10T10:56:04","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8325"},"modified":"2020-09-10T10:56:04","modified_gmt":"2020-09-10T10:56:04","slug":"medical-device-remote-jobs-when-to-hire-freelancers","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-remote-jobs-when-to-hire-freelancers\/","title":{"rendered":"Trabalhos remotos com dispositivos m\u00e9dicos: Quando contratar freelancers"},"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-69f6313738168\" 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-69f6313738168\"><\/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-remote-jobs-when-to-hire-freelancers\/#Regulatory_writing\" title=\"Escrita regulamentar\">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-remote-jobs-when-to-hire-freelancers\/#Statistical_verification_for_clinical_trials\" title=\"Verifica\u00e7\u00e3o estat\u00edstica para ensaios cl\u00ednicos\">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-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-remote-jobs-when-to-hire-freelancers\/#Literature_searches\" title=\"Pesquisas bibliogr\u00e1ficas\">Pesquisas bibliogr\u00e1ficas<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Os fabricantes de dispositivos m\u00e9dicos em todo o mundo est\u00e3o trabalhando remotamente pela primeira vez. Embora muitas fun\u00e7\u00f5es de P&amp;D n\u00e3o possam ser realizadas virtualmente, aqui est\u00e3o algumas \u00e1reas de trabalhos remotos de produtos m\u00e9dicos que as empresas podem terceirizar para consultores ou freelancers.\u00a0\u00a0<\/em><\/p>\n<p>Trazer um dispositivo m\u00e9dico para o mercado \u00e9 um processo complexo que envolve v\u00e1rias etapas, incluindo desenvolvimento e valida\u00e7\u00e3o de produtos, testes cl\u00ednicos e aprova\u00e7\u00f5es regulat\u00f3rias. Devido \u00e0 pandemia da COVID-19, as empresas de produtos m\u00e9dicos podem achar mais dif\u00edcil acessar as habilidades especializadas necess\u00e1rias para obter a aprova\u00e7\u00e3o do FDA ou as marcas CE para produtos atuais, ou trazer novos produtos para o mercado. Uma maneira de ter acesso \u00e0s habilidades especializadas durante a pandemia \u00e9 colaborar com uma <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">consultor de dispositivos m\u00e9dicos<\/a>que podem trabalhar remotamente em projetos regulat\u00f3rios, de ensaios cl\u00ednicos ou estat\u00edsticos.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_writing\"><\/span>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 dispositivos m\u00e9dicos (MDR) devem obter uma antes de poderem vender seu dispositivo na UE. A atual diretiva de produtos m\u00e9dicos (MDD) termina em 2021. Da mesma forma, aqueles que trazem novos produtos ao mercado para enfrentar a pandemia precisar\u00e3o de acesso r\u00e1pido a especialistas em regulamenta\u00e7\u00e3o para obter a aprova\u00e7\u00e3o dos produtos. Nos EUA, os dispositivos m\u00e9dicos precisam obter aprova\u00e7\u00f5es da FDA para seu dispositivo antes que ele possa ser disponibilizado. A <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Consultor FDA 510(k)<\/a> pode ajudar a preparar os documentos de apresenta\u00e7\u00e3o e garantir que eles atendam a todos os requisitos.<\/p>\n<p>A avalia\u00e7\u00e3o cl\u00ednica \u00e9 uma grande parte da reformula\u00e7\u00e3o dos Regulamentos de Dispositivos M\u00e9dicos na UE. <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Consultores de avalia\u00e7\u00e3o cl\u00ednica<\/a> pode ajudar na elabora\u00e7\u00e3o do relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica (CER), para o qual 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<h2><span class=\"ez-toc-section\" id=\"Statistical_verification_for_clinical_trials\"><\/span>Verifica\u00e7\u00e3o estat\u00edstica para ensaios cl\u00ednicos<span class=\"ez-toc-section-end\"><\/span><\/h2>\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=MedDevice-Remote\">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<h2><span class=\"ez-toc-section\" id=\"Literature_searches\"><\/span>Pesquisas bibliogr\u00e1ficas<span class=\"ez-toc-section-end\"><\/span><\/h2>\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=MedDevice-Remote\">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. \u00c0 medida que mais e mais especialistas se mudam para o trabalho remoto, os fabricantes agora t\u00eam um grupo maior de especialistas aut\u00f4nomos que podem explorar.<\/p>\n<p><strong>Procurando terceirizar seus trabalhos remotos de dispositivos m\u00e9dicos? Veja <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">consultores em dispositivos m\u00e9dicos<\/a> em Kolabtree ou <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">postar um projeto de gra\u00e7a<\/a> para obter cita\u00e7\u00f5es.\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Medical device manufacturers worldwide are working remotely for the first time. While many R&amp;D functions cannot be done virtually, here are some areas medical device remote jobs that companies can look at outsourcing to consultants or freelancers.\u00a0\u00a0 Bringing a medical device to market is a complex processes involving several steps including product development and validation,<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-remote-jobs-when-to-hire-freelancers\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":8328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[304,403,443,540],"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 Remote Jobs: When to Hire Freelancers<\/title>\n<meta name=\"description\" content=\"Medical device remote jobs can help the medtech industry access resources quickly and easily. Here are three areas that can be outsourced.\" \/>\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\/medical-device-remote-jobs-when-to-hire-freelancers\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Remote Jobs: When to Hire Freelancers\" \/>\n<meta property=\"og:description\" content=\"Medical device remote jobs can help the medtech industry access resources quickly and easily. Here are three areas that can be outsourced.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-remote-jobs-when-to-hire-freelancers\/\" \/>\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=\"2020-09-10T10:56:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/09\/medical-device-remote-jobs.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"626\" \/>\n\t<meta property=\"og:image:height\" content=\"294\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\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=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Remote Jobs: When to Hire Freelancers","description":"Medical device remote jobs can help the medtech industry access resources quickly and easily. 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