{"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\/es\/empleos-medicos-remotos-cuando-se-contrata-a-trabajadores-gratuitos\/","title":{"rendered":"Trabajos a distancia en dispositivos m\u00e9dicos: Cu\u00e1ndo contratar aut\u00f3nomos"},"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-69f60d82c157e\" 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-69f60d82c157e\"><\/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\/empleos-medicos-remotos-cuando-se-contrata-a-trabajadores-gratuitos\/#Regulatory_writing\" title=\"Redacci\u00f3n de la normativa\">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\/empleos-medicos-remotos-cuando-se-contrata-a-trabajadores-gratuitos\/#Statistical_verification_for_clinical_trials\" title=\"Verificaci\u00f3n estad\u00edstica de los ensayos cl\u00ednicos\">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-3\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/empleos-medicos-remotos-cuando-se-contrata-a-trabajadores-gratuitos\/#Literature_searches\" title=\"B\u00fasquedas bibliogr\u00e1ficas\">B\u00fasquedas bibliogr\u00e1ficas<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Los fabricantes de dispositivos m\u00e9dicos de todo el mundo est\u00e1n trabajando a distancia por primera vez. Aunque muchas funciones de I+D no pueden realizarse de forma virtual, a continuaci\u00f3n se detallan algunas \u00e1reas de trabajo a distancia de dispositivos m\u00e9dicos que las empresas pueden considerar para subcontratar a consultores o aut\u00f3nomos.\u00a0\u00a0<\/em><\/p>\n<p>La introducci\u00f3n de un producto sanitario en el mercado es un proceso complejo que implica varios pasos, como el desarrollo y la validaci\u00f3n del producto, los ensayos cl\u00ednicos y las aprobaciones reglamentarias. Debido a la pandemia de COVID-19, las empresas de productos sanitarios pueden tener m\u00e1s dificultades para acceder a los conocimientos especializados necesarios para obtener la aprobaci\u00f3n de la FDA o el marcado CE para los productos actuales, o para introducir nuevos productos en el mercado. Una forma de acceder a los conocimientos especializados durante la pandemia es colaborar con un <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 puedan trabajar a distancia en proyectos de reglamentaci\u00f3n, ensayos cl\u00ednicos o estad\u00edsticas.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_writing\"><\/span>Redacci\u00f3n de la normativa<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Los fabricantes que a\u00fan no tienen el marcado CE para sus productos seg\u00fan la normativa sobre productos sanitarios (MDR) deben obtenerlo antes de poder vender su dispositivo en la UE. La actual directiva sobre productos sanitarios (MDD) termina en 2021. Del mismo modo, los que introduzcan nuevos productos en el mercado para hacer frente a la pandemia necesitar\u00e1n un r\u00e1pido acceso a los especialistas en reglamentaci\u00f3n para conseguir la aprobaci\u00f3n de los productos. En EE.UU., los productos sanitarios necesitan obtener la aprobaci\u00f3n de la FDA para su dispositivo antes de que pueda estar disponible. 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 de la FDA 510(k)<\/a> puede ayudar a preparar los documentos de presentaci\u00f3n y asegurarse de que cumplen todos los requisitos.<\/p>\n<p>La evaluaci\u00f3n cl\u00ednica es una parte importante de la renovaci\u00f3n de la normativa sobre productos sanitarios en la 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 evaluaci\u00f3n cl\u00ednica<\/a> puede ayudar a elaborar el informe de evaluaci\u00f3n cl\u00ednica (CER), para el que el MDR exige ahora muchos m\u00e1s detalles.<\/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<h2><span class=\"ez-toc-section\" id=\"Statistical_verification_for_clinical_trials\"><\/span>Verificaci\u00f3n estad\u00edstica de los ensayos cl\u00ednicos<span class=\"ez-toc-section-end\"><\/span><\/h2>\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=MedDevice-Remote\">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<h2><span class=\"ez-toc-section\" id=\"Literature_searches\"><\/span>B\u00fasquedas 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\/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=MedDevice-Remote\">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. Como cada vez hay m\u00e1s especialistas que se pasan al trabajo a distancia, los fabricantes tienen ahora una mayor reserva de expertos aut\u00f3nomos a la que pueden recurrir.<\/p>\n<p><strong>\u00bfDesea subcontratar sus trabajos remotos de dispositivos m\u00e9dicos? Ver <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 de dispositivos m\u00e9dicos<\/a> en Kolabtree o <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">publicar un proyecto de forma gratuita<\/a> para obtener presupuestos.\u00a0<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Los fabricantes de dispositivos m\u00e9dicos de todo el mundo est\u00e1n trabajando a distancia por primera vez. Aunque muchas funciones de I+D no pueden realizarse de forma virtual, a continuaci\u00f3n se indican algunas \u00e1reas de trabajo a distancia de productos sanitarios que las empresas pueden considerar para subcontratar a consultores o aut\u00f3nomos.   Llevar un producto sanitario al mercado es un proceso complejo que implica varios pasos, como el desarrollo y la validaci\u00f3n del producto,<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/es\/empleos-medicos-remotos-cuando-se-contrata-a-trabajadores-gratuitos\/\" title=\"Leer m\u00e1s\">Leer m\u00e1s<\/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\/es\/medical-device-remote-jobs-when-to-hire-freelancers\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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. 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