{"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\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/","title":{"rendered":"Lavori a distanza per dispositivi medici: Quando assumere freelance"},"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\">Indice dei contenuti<\/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-69f60d61d6329\" 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-69f60d61d6329\"><\/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\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/#Regulatory_writing\" title=\"Scrittura normativa\">Scrittura normativa<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/#Statistical_verification_for_clinical_trials\" title=\"Verifica statistica per gli studi clinici\">Verifica statistica per gli studi clinici<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/#Literature_searches\" title=\"Ricerche nella letteratura\">Ricerche nella letteratura<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>I produttori di dispositivi medici in tutto il mondo stanno lavorando in remoto per la prima volta. Mentre molte funzioni di R&amp;S non possono essere fatte virtualmente, qui ci sono alcune aree di lavoro remoto di dispositivi medici che le aziende possono guardare all'outsourcing a consulenti o freelance.\u00a0\u00a0<\/em><\/p>\n<p>Portare un dispositivo medico sul mercato \u00e8 un processo complesso che coinvolge diverse fasi tra cui lo sviluppo e la convalida del prodotto, i test clinici e le approvazioni normative. A causa della pandemia di COVID-19, le aziende di dispositivi medici possono trovare pi\u00f9 difficile accedere alle competenze specialistiche necessarie per ottenere l'approvazione FDA o i marchi CE per i prodotti attuali, o portare nuovi prodotti sul mercato. Un modo per accedere a competenze specialistiche durante la pandemia \u00e8 quello di collaborare 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\">consulente per dispositivi medici<\/a>che pu\u00f2 lavorare a distanza su progetti di regolamentazione, di sperimentazione clinica o statistica.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_writing\"><\/span>Scrittura normativa<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>I produttori che non hanno gi\u00e0 un marchio CE per i loro prodotti secondo la normativa sui dispositivi medici (MDR) devono ottenerne uno prima di poter vendere il loro dispositivo nell'UE. L'attuale direttiva sui dispositivi medici (MDD) termina nel 2021. Allo stesso modo, coloro che portano nuovi prodotti sul mercato per affrontare la pandemia avranno bisogno di un rapido accesso agli specialisti di regolamentazione per ottenere l'approvazione dei prodotti. Negli Stati Uniti, i dispositivi medici devono ottenere l'approvazione della FDA per il loro dispositivo prima che possa essere reso disponibile. 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\">Consulente FDA 510(k)<\/a> pu\u00f2 aiutare a preparare i documenti di presentazione e assicurarsi che soddisfino tutti i requisiti.<\/p>\n<p>La valutazione clinica \u00e8 una parte enorme del rinnovamento dei regolamenti sui dispositivi medici nell'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\">Consulenti per la valutazione clinica<\/a> pu\u00f2 aiutare a sviluppare il rapporto di valutazione clinica (CER), per il quale la MDR ora richiede molti pi\u00f9 dettagli.<\/p>\n<p>Le aziende di dispositivi medici possono cercare un freelance esperto nella gestione di progetti clinici, nella scrittura tecnica e con un'ampia conoscenza del panorama normativo, per aiutare in questo compito.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Statistical_verification_for_clinical_trials\"><\/span>Verifica statistica per gli studi clinici<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Per ottenere un marchio CE sotto la MDR, i produttori di prodotti esistenti potrebbero dover condurre ulteriori studi clinici. I produttori di nuovi prodotti che sono stati progettati per contribuire allo sforzo COVID-19, possono anche essere sotto pressione per ottenere prove completate rapidamente.<\/p>\n<p>Condurre l'analisi statistica dei dati degli studi clinici lontano dal laboratorio pu\u00f2 essere una sfida perch\u00e9 i produttori possono non avere la potenza di calcolo e il software necessario quando lavorano da casa.<\/p>\n<p>Un modo per aggirare questa sfida \u00e8 reclutare un <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">biostatistico remoto<\/a> o uno specialista simile esperto nella gestione dei dati per eseguire compiti come la compilazione di schede tecniche o la scrittura di algoritmi per il vostro studio clinico. Come risultato, puoi stare al passo con i tuoi dati e monitorare gli effetti dei tuoi dispositivi.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_searches\"><\/span>Ricerche nella letteratura<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\/it\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">ricerca<\/a> papers or a medical database, such as MEDLINE.<\/p>\n<p>Pu\u00f2 anche includere informazioni dai concorrenti, per esempio se il produttore sta cercando di rivendicare l'equivalenza.<\/p>\n<p>Un 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\">consulente per la ricerca di letteratura<\/a> \u00e8 in grado di eseguire tutte le fasi. Usando un protocollo standardizzato, possono anche ripetere queste ricerche nei successivi aggiornamenti delle CER. Poich\u00e9 le CER non saranno pi\u00f9 un documento statico sotto la MDR, e dovranno essere aggiornate periodicamente, questo \u00e8 un approccio lungimirante.<\/p>\n<p>Anche se lavorare da casa \u00e8 ora \"una necessit\u00e0\" per molti produttori di dispositivi medici, non deve essere una barriera. Poich\u00e9 sempre pi\u00f9 specialisti si spostano verso il lavoro a distanza, i produttori hanno ora un pool pi\u00f9 ampio di esperti freelance a cui attingere.<\/p>\n<p><strong>Stai cercando di esternalizzare i tuoi lavori a distanza di dispositivi medici? Vedi <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">consulenti di dispositivi medici<\/a> su Kolabtree o <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">pubblica un progetto gratuitamente<\/a> per ottenere dei preventivi.\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\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/\" title=\"Per saperne di pi\u00f9\">Per saperne di pi\u00f9<\/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\/it\/medical-device-remote-jobs-when-to-hire-freelancers\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\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\/it\/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=\"Scritto da\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tempo di lettura stimato\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minuti\" \/>\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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