{"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\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/","title":{"rendered":"Medizinische Ger\u00e4te-Fernarbeit: Wann man Freiberufler anheuert"},"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\">Das Inhaltsverzeichnis<\/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-69f60d63db970\" 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-69f60d63db970\"><\/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\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/#Regulatory_writing\" title=\"Rechtliches Schreiben\">Rechtliches Schreiben<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/#Statistical_verification_for_clinical_trials\" title=\"Statistische \u00dcberpr\u00fcfung f\u00fcr klinische Studien\">Statistische \u00dcberpr\u00fcfung f\u00fcr klinische Studien<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/#Literature_searches\" title=\"Literaturrecherchen\">Literaturrecherchen<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Hersteller medizinischer Ger\u00e4te arbeiten weltweit zum ersten Mal aus der Ferne. W\u00e4hrend viele F&amp;E-Funktionen nicht virtuell ausgef\u00fchrt werden k\u00f6nnen, gibt es einige Bereiche, in denen Unternehmen die Fernarbeit in der Medizintechnik an Berater oder Freiberufler auslagern k\u00f6nnen.\u00a0\u00a0<\/em><\/p>\n<p>Die Markteinf\u00fchrung eines Medizinprodukts ist ein komplexer Prozess, der mehrere Schritte umfasst, darunter Produktentwicklung und -validierung, klinische Versuche und beh\u00f6rdliche Genehmigungen. Aufgrund der COVID-19-Pandemie kann es f\u00fcr Medizinprodukteunternehmen schwieriger sein, Zugang zu den Fachkenntnissen zu erhalten, die erforderlich sind, um die FDA-Zulassung oder CE-Kennzeichnung f\u00fcr aktuelle Produkte zu erhalten oder neue Produkte auf den Markt zu bringen. Eine M\u00f6glichkeit, w\u00e4hrend der Pandemie auf Fachkenntnisse zuzugreifen, besteht in der Zusammenarbeit mit einer <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Berater f\u00fcr Medizinprodukte<\/a>die aus der Ferne an Projekten in den Bereichen Regulierung, klinische Pr\u00fcfungen oder Statistik arbeiten k\u00f6nnen.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_writing\"><\/span>Rechtliches Schreiben<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Hersteller, die noch nicht \u00fcber eine CE-Kennzeichnung f\u00fcr ihre Produkte gem\u00e4\u00df der Medizinprodukteverordnung (MDR) verf\u00fcgen, m\u00fcssen eine solche erhalten, bevor sie ihr Produkt in der EU verkaufen k\u00f6nnen. Die derzeitige Medizinprodukterichtlinie (MDD) l\u00e4uft 2021 aus. Ebenso werden diejenigen, die neue Produkte zur Bek\u00e4mpfung der Pandemie auf den Markt bringen, schnellen Zugang zu Zulassungsspezialisten ben\u00f6tigen, um ihre Produkte genehmigen zu lassen. In den USA m\u00fcssen Medizinprodukte erst von der FDA zugelassen werden, bevor sie auf den Markt kommen k\u00f6nnen. 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) Berater<\/a> kann bei der Vorbereitung der Einreichungsunterlagen helfen und sicherstellen, dass sie allen Anforderungen entsprechen.<\/p>\n<p>Die klinische Bewertung ist ein wichtiger Bestandteil der \u00dcberarbeitung der Medizinprodukteverordnungen in der 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\">Berater f\u00fcr klinische Bewertung<\/a> kann bei der Ausarbeitung des klinischen Bewertungsberichts (CER) helfen, f\u00fcr den die MDR jetzt viel mehr Details verlangt.<\/p>\n<p>Medizintechnikunternehmen k\u00f6nnen sich f\u00fcr diese Aufgabe einen Freiberufler suchen, der Erfahrung im klinischen Projektmanagement und im technischen Schreiben hat und \u00fcber ein breites Wissen im Bereich der Rechtsvorschriften verf\u00fcgt.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Statistical_verification_for_clinical_trials\"><\/span>Statistische \u00dcberpr\u00fcfung f\u00fcr klinische Studien<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Um eine CE-Kennzeichnung im Rahmen der MDR zu erhalten, m\u00fcssen die Hersteller bestehender Produkte m\u00f6glicherweise zus\u00e4tzliche klinische Studien durchf\u00fchren. Hersteller neuer Produkte, die als Beitrag zu den COVID-19-Bem\u00fchungen entwickelt wurden, k\u00f6nnten ebenfalls unter dem Druck stehen, die Studien schnell abzuschlie\u00dfen.<\/p>\n<p>Die statistische Analyse von Daten aus klinischen Studien au\u00dferhalb des Labors kann eine Herausforderung darstellen, da den Herstellern bei der Arbeit von zu Hause aus die n\u00f6tige Rechenleistung und Software fehlen kann.<\/p>\n<p>Eine M\u00f6glichkeit, diese Herausforderung zu umgehen, ist die Einstellung eines <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Fernbiostatistiker<\/a> oder einen \u00e4hnlichen Spezialisten, der sich mit der Verwaltung von Daten auskennt, um Aufgaben wie die Zusammenstellung von Datenbl\u00e4ttern oder das Schreiben von Algorithmen f\u00fcr Ihre klinische Studie zu \u00fcbernehmen. Auf diese Weise behalten Sie den \u00dcberblick \u00fcber Ihre Daten und k\u00f6nnen die Auswirkungen Ihrer Ger\u00e4te \u00fcberwachen.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_searches\"><\/span>Literaturrecherchen<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\/de\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">Forschung<\/a> papers or a medical database, such as MEDLINE.<\/p>\n<p>Sie kann auch Informationen von Konkurrenten enthalten, zum Beispiel wenn der Hersteller versucht, die Gleichwertigkeit zu behaupten.<\/p>\n<p>Ein Freiberufler <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/literature-search\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Berater f\u00fcr Literaturrecherche<\/a> in der Lage ist, alle Schritte durchzuf\u00fchren. Durch die Verwendung eines standardisierten Protokolls k\u00f6nnen sie diese Abfragen auch bei sp\u00e4teren CER-Aktualisierungen wiederholen. Da die CER nach der MDR kein statisches Dokument mehr sein wird und regelm\u00e4\u00dfig aktualisiert werden muss, ist dies ein zukunftsorientierter Ansatz.<\/p>\n<p>Obwohl die Arbeit von zu Hause aus f\u00fcr viele Hersteller medizinischer Ger\u00e4te inzwischen \"eine Notwendigkeit\" ist, muss dies kein Hindernis sein. Da immer mehr Fachleute aus der Ferne arbeiten, steht den Herstellern nun ein gr\u00f6\u00dferer Pool freiberuflicher Experten zur Verf\u00fcgung, auf den sie zur\u00fcckgreifen k\u00f6nnen.<\/p>\n<p><strong>M\u00f6chten Sie Ihre Jobs in der Medizintechnik auslagern? Siehe <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">Berater f\u00fcr medizinische Ger\u00e4te<\/a> auf Kolabtree oder <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MedDevice-Remote\">ein Projekt kostenlos einstellen<\/a> um Angebote einzuholen.\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\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/\" title=\"Mehr lesen\">Mehr lesen<\/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\/de\/medical-device-remote-jobs-when-to-hire-freelancers\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/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=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"3\u00a0Minuten\" \/>\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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