{"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\/medical-device-freelancers-how-can-remote-experts-help\/","title":{"rendered":"Medical Device Freelancers: How Can Remote Experts Help?"},"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-69f64e297c8e9\" 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-69f64e297c8e9\"><\/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-freelancers-how-can-remote-experts-help\/#1_Regulatory_writing\" title=\"1. Regulatory writing\">1. 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-freelancers-how-can-remote-experts-help\/#2_Verification_of_materials_for_new_PPE_or_equipment\" title=\"2. Verification of materials for new PPE or equipment\">2. Verification of materials for new PPE or equipment<\/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-freelancers-how-can-remote-experts-help\/#3_Statistical_verification_for_clinical_trials\" title=\"3. Statistical verification for clinical trials\">3. Statistical verification for clinical trials<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-freelancers-how-can-remote-experts-help\/#4_Literature_searches\" title=\"4. Literature searches\">4. Literature searches<\/a><\/li><\/ul><\/nav><\/div>\n<p>As the freelance revolution takes over the world, here&#8217;s a look at how hiring <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">medical device freelancers<\/a> can help you grow quickly and easily.<\/p>\n<p>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 staff in laboratories and keep all employees working from home wherever possible.<\/p>\n<p>In light of the pandemic, medical device companies may find it more difficult to access the specialist skills needed to obtain CE marks for current products, or bring new products to market. One way to access specialist skills during the pandemic is consulting an experienced medical device freelancer, who can work remotely on regulatory, clinical trial or statistical projects. How can medical device consultants help remotely?<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Regulatory_writing\"><\/span>1. 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 obtain one so that they can sell the device in the EU once the transition from the current medical device directive (MDD) ends in 2021.<\/p>\n<p>Similarly, those bringing new products to market to address the pandemic will need quick access to <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">regulatory affairs consultants<\/a> to get products approved.A freelancer can help complete documentation in the technical file, such as clinical evaluation reports (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<h3><span class=\"ez-toc-section\" id=\"2_Verification_of_materials_for_new_PPE_or_equipment\"><\/span>2. Verification of materials for new PPE or equipment<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The COVID-19 pandemic has sparked a shortage in facemasks and gowns and many institutions are having to reuse equipment. Businesses are springing into action to help, for example technical textiles manufacturer Milliken &amp; Company is now producing critical barrier protection fabrics for gowns and headcovers.<\/p>\n<p>Before hospital staff can use the equipment, these new designs need to be verified and the materials checked for safety and efficacy.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Statistical_verification_for_clinical_trials\"><\/span><span style=\"font-size: 18px;\">3. Statistical verification for clinical trials<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\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=MDFreelancer\">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<h3><span class=\"ez-toc-section\" id=\"4_Literature_searches\"><\/span>4. Literature searches<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\/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=MDFreelancer\">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.<\/p>\n<p><strong>Ready to hire <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">medical device freelancers<\/a>? Post your project on Kolabtree for free and get quotes from experts. <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">POST A PROJECT NOW<\/a><\/strong><\/p>\n","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\/medical-device-freelancers-how-can-remote-experts-help\/\" title=\"Read More\">Read More<\/a><\/div>\n","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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