{"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\/medical-device-remote-jobs-when-to-hire-freelancers\/","title":{"rendered":"Medical Device Remote Jobs: When to Hire 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\">Table of Contents<\/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-69f60d42296e6\" 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-69f60d42296e6\"><\/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\/medical-device-remote-jobs-when-to-hire-freelancers\/#Regulatory_writing\" title=\"Regulatory writing\">Regulatory writing<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-remote-jobs-when-to-hire-freelancers\/#Statistical_verification_for_clinical_trials\" title=\"Statistical verification for clinical trials\">Statistical verification for clinical trials<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-remote-jobs-when-to-hire-freelancers\/#Literature_searches\" title=\"Literature searches\">Literature searches<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>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<\/em><\/p>\n<p>Bringing a medical device to market is a complex processes involving several steps including product development and validation, clinical trials and regulatory approvals. Due to the COVID-19 pandemic,\u00a0 medical device companies may find it more difficult to access the specialist skills needed to obtain FDA approval or CE marks for current products, or bring new products to market. One way to access specialist skills during the pandemic is to collaborate with a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">medical device consultant<\/a>, who can work remotely on regulatory, clinical trial or statistical projects.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_writing\"><\/span>Regulatory writing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Manufacturers that do not already have a CE mark for their products under the medical device regulations (MDR) must get one before they can sell their device in the EU. The current medical device directive (MDD) ends in 2021. Similarly, those bringing new products to market to address the pandemic will need quick access to regulatory specialists to get products approved. In the US, medical devices need to get FDA approvals for their device before it can be made available. 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\">FDA 510(k) consultant<\/a> can help prepare the submission documents and ensure they meet all requirements.<\/p>\n<p>Clinical evaluation is huge part of the revamp to the Medical Device Regulations in the EU. <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\">Clinical evaluation consultants<\/a> can help with developing the clinical evaluation report (CER), for which the MDR now requires much more detail.<\/p>\n<p>Medical device companies can look for a freelancer experienced in clinical project management, technical writing and with a broad knowledge of the regulatory landscape, to help with this task.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Statistical_verification_for_clinical_trials\"><\/span>Statistical verification for clinical trials<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>To gain a CE mark under the MDR, manufacturers of existing products may have to conduct additional clinical trials. Manufacturers of new products that have been designed to contribute to the COVID-19 effort, may also be under pressure to get trials completed quickly.<\/p>\n<p>Conducting statistical analysis of clinical trial data away from the laboratory can be a challenge because manufacturers can lack the computing power and necessary software when working from home.<\/p>\n<p>One way around this challenge is to recruit a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">remote biostatistician<\/a> or similar specialist skilled in managing data to perform tasks like compiling datasheets or writing algorithms for your clinical study. As a result, you can stay on top of your data and monitor the effects of your devices.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_searches\"><\/span>Literature searches<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\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> papers or a medical database, such as MEDLINE.<\/p>\n<p>It can also include information from competitors, for example if the manufacturer is trying to claim equivalence.<\/p>\n<p>A 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\">literature search consultant<\/a> is able to perform all stages. By using a standardised protocol, they can also repeat these searches across subsequent CER updates. As CERs will no longer be a static document under the MDR, and will have to be periodically updated, this is a forward-looking approach.<\/p>\n<p>Although working from home is now \u201ca necessity\u201d for many medical device manufacturers, it doesn\u2019t have to be a barrier. As more and more specialists move to remote working, manufacturers now have a larger pool of freelance experts they can tap into.<\/p>\n<p><strong>Looking to outsource your medical device remote jobs? View <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">medical device consultants<\/a> on Kolabtree or <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">post a project for free<\/a> to get quotes.\u00a0<\/strong><\/p>\n","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\/medical-device-remote-jobs-when-to-hire-freelancers\/\" title=\"Read More\">Read More<\/a><\/div>\n","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. 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