{"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\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/","title":{"rendered":"Aut\u00f3nomos de dispositivos m\u00e9dicos: \u00bfC\u00f3mo pueden ayudar los expertos a distancia?"},"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\">Tabla de contenidos<\/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-69f64e53e4d27\" aria-label=\"Tabla de contenidos\"><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-69f64e53e4d27\"><\/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\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/#1_Regulatory_writing\" title=\"1. Redacci\u00f3n de la normativa\">1. Redacci\u00f3n de la normativa<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/#2_Verification_of_materials_for_new_PPE_or_equipment\" title=\"2. Verificaci\u00f3n de los materiales para los nuevos EPI o equipos\">2. Verificaci\u00f3n de los materiales para los nuevos EPI o equipos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/#3_Statistical_verification_for_clinical_trials\" title=\"3. Verificaci\u00f3n estad\u00edstica de los ensayos cl\u00ednicos\">3. Verificaci\u00f3n estad\u00edstica de los ensayos 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\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/#4_Literature_searches\" title=\"4. B\u00fasquedas bibliogr\u00e1ficas\">4. B\u00fasquedas bibliogr\u00e1ficas<\/a><\/li><\/ul><\/nav><\/div>\n<p>A medida que la revoluci\u00f3n de los aut\u00f3nomos se apodera del mundo, he aqu\u00ed un vistazo a c\u00f3mo 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\u00f3nomos de dispositivos m\u00e9dicos<\/a> puede ayudarle a crecer r\u00e1pida y f\u00e1cilmente.<\/p>\n<p>Oval Medical Technologies, empresa especializada en la administraci\u00f3n de f\u00e1rmacos, es s\u00f3lo un ejemplo de empresa m\u00e9dica que se pasa al trabajo a distancia. La empresa anunci\u00f3 que reducir\u00eda al m\u00ednimo el personal de los laboratorios y mantendr\u00eda a todos los empleados trabajando desde casa siempre que fuera posible.<\/p>\n<p>A la luz de la pandemia, las empresas de productos sanitarios pueden tener m\u00e1s dificultades para acceder a los conocimientos especializados necesarios para obtener el marcado CE de los productos actuales o para introducir nuevos productos en el mercado. Una forma de acceder a los conocimientos especializados durante la pandemia es consultar a un aut\u00f3nomo con experiencia en productos sanitarios, que puede trabajar a distancia en proyectos de regulaci\u00f3n, ensayos cl\u00ednicos o estad\u00edsticas. \u00bfC\u00f3mo pueden ayudar los consultores de productos sanitarios a distancia?<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Regulatory_writing\"><\/span>1. Redacci\u00f3n de la normativa<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Los fabricantes que a\u00fan no dispongan de un marcado CE para sus productos conforme a la normativa sobre productos sanitarios (MDR) deben obtenerlo para poder vender el producto en la UE una vez que finalice la transici\u00f3n de la actual directiva sobre productos sanitarios (MDD) en 2021.<\/p>\n<p>Del mismo modo, los que saquen al mercado nuevos productos para hacer frente a la pandemia necesitar\u00e1n un acceso 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 de asuntos reglamentarios<\/a> Un aut\u00f3nomo puede ayudar a completar la documentaci\u00f3n del expediente t\u00e9cnico, como los informes de evaluaci\u00f3n cl\u00ednica (CER), para los que el MDR exige ahora mucho m\u00e1s detalle.<\/p>\n<p>Las empresas de productos sanitarios pueden buscar un aut\u00f3nomo con experiencia en gesti\u00f3n de proyectos cl\u00ednicos, redacci\u00f3n t\u00e9cnica y con un amplio conocimiento del panorama normativo, para que les ayude en esta tarea.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Verification_of_materials_for_new_PPE_or_equipment\"><\/span>2. Verificaci\u00f3n de los materiales para los nuevos EPI o equipos<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>La pandemia de COVID-19 ha provocado una escasez de mascarillas y batas, y muchas instituciones est\u00e1n teniendo que reutilizar el equipo. Las empresas est\u00e1n actuando para ayudar, por ejemplo, el fabricante de textiles t\u00e9cnicos Milliken &amp; Company est\u00e1 produciendo ahora tejidos de protecci\u00f3n de barrera cr\u00edtica para batas y cubrecabezas.<\/p>\n<p>Antes de que el personal del hospital pueda utilizar los equipos, es necesario verificar estos nuevos dise\u00f1os y comprobar la seguridad y eficacia de los materiales.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Statistical_verification_for_clinical_trials\"><\/span><span style=\"font-size: 18px;\">3. Verificaci\u00f3n estad\u00edstica de los ensayos cl\u00ednicos<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Para obtener la marca CE en virtud del MDR, los fabricantes de productos existentes pueden tener que realizar ensayos cl\u00ednicos adicionales. Los fabricantes de nuevos productos que han sido dise\u00f1ados para contribuir al esfuerzo de COVID-19, tambi\u00e9n pueden estar bajo presi\u00f3n para completar los ensayos r\u00e1pidamente.<\/p>\n<p>Llevar a cabo el an\u00e1lisis estad\u00edstico de los datos de los ensayos cl\u00ednicos fuera del laboratorio puede ser un reto porque los fabricantes pueden carecer de la potencia inform\u00e1tica y el software necesario cuando trabajan desde casa.<\/p>\n<p>Una forma de superar este reto es contratar a un <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">bioestad\u00edstico a distancia<\/a> o un especialista similar con experiencia en la gesti\u00f3n de datos para realizar tareas como la compilaci\u00f3n de hojas de datos o la redacci\u00f3n de algoritmos para su estudio cl\u00ednico. Como resultado, podr\u00e1 estar al tanto de sus datos y controlar los efectos de sus dispositivos.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Literature_searches\"><\/span>4. B\u00fasquedas 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\/es\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">investigaci\u00f3n<\/a> papers or a medical database, such as MEDLINE.<\/p>\n<p>Tambi\u00e9n puede incluir informaci\u00f3n de los competidores, por ejemplo, si el fabricante est\u00e1 tratando de reclamar la equivalencia.<\/p>\n<p>Un aut\u00f3nomo <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 b\u00fasqueda bibliogr\u00e1fica<\/a> es capaz de realizar todas las etapas. Al utilizar un protocolo estandarizado, tambi\u00e9n pueden repetir estas b\u00fasquedas en las siguientes actualizaciones de las RCE. Dado que las RCE ya no ser\u00e1n un documento est\u00e1tico en el marco del MDR, y tendr\u00e1n que actualizarse peri\u00f3dicamente, se trata de un enfoque orientado al futuro.<\/p>\n<p>Aunque trabajar desde casa es ahora \"una necesidad\" para muchos fabricantes de dispositivos m\u00e9dicos, no tiene por qu\u00e9 ser un obst\u00e1culo.<\/p>\n<p><strong>Listo 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\u00f3nomos de dispositivos m\u00e9dicos<\/a>? Publica tu proyecto en Kolabtree de forma gratuita y obt\u00e9n presupuestos de expertos. <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">PUBLICAR UN PROYECTO AHORA<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A medida que la revoluci\u00f3n de los aut\u00f3nomos se apodera del mundo, aqu\u00ed vemos c\u00f3mo la contrataci\u00f3n de aut\u00f3nomos de dispositivos m\u00e9dicos puede ayudarle a crecer de forma r\u00e1pida y sencilla. Oval Medical Technologies, empresa especializada en la administraci\u00f3n de f\u00e1rmacos, es s\u00f3lo un ejemplo de empresa m\u00e9dica que se pasa al trabajo a distancia. La empresa anunci\u00f3 que minimizar\u00eda el n\u00famero de<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/es\/medicos-distribuidores-como-pueden-ayudar-los-expertos-removidos\/\" title=\"Leer m\u00e1s\">Leer m\u00e1s<\/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 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