{"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\/fr\/medical-device-freelancers-how-can-remote-experts-help\/","title":{"rendered":"Pigistes sp\u00e9cialis\u00e9s dans les dispositifs m\u00e9dicaux : Comment les experts \u00e0 distance peuvent-ils aider ?"},"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 des mati\u00e8res<\/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-69f6223020a1a\" aria-label=\"Table des mati\u00e8res\"><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-69f6223020a1a\"><\/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\/fr\/medical-device-freelancers-how-can-remote-experts-help\/#1_Regulatory_writing\" title=\"1. R\u00e9daction de la r\u00e9glementation\">1. R\u00e9daction de la r\u00e9glementation<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-freelancers-how-can-remote-experts-help\/#2_Verification_of_materials_for_new_PPE_or_equipment\" title=\"2. V\u00e9rification des mat\u00e9riaux pour les nouveaux EPI ou \u00e9quipements\">2. V\u00e9rification des mat\u00e9riaux pour les nouveaux EPI ou \u00e9quipements<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-freelancers-how-can-remote-experts-help\/#3_Statistical_verification_for_clinical_trials\" title=\"3. V\u00e9rification statistique pour les essais cliniques\">3. V\u00e9rification statistique pour les essais cliniques<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-freelancers-how-can-remote-experts-help\/#4_Literature_searches\" title=\"4. Recherche documentaire\">4. Recherche documentaire<\/a><\/li><\/ul><\/nav><\/div>\n<p>Alors que la r\u00e9volution du freelance s'empare du monde, voici un aper\u00e7u de la fa\u00e7on dont l'embauche <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">freelances sp\u00e9cialis\u00e9s dans les dispositifs m\u00e9dicaux<\/a> peut vous aider \u00e0 vous d\u00e9velopper rapidement et facilement.<\/p>\n<p>Oval Medical Technologies, une soci\u00e9t\u00e9 sp\u00e9cialis\u00e9e dans l'administration de m\u00e9dicaments, n'est qu'un exemple parmi d'autres d'une entreprise m\u00e9dicale qui s'oriente vers le travail \u00e0 distance. La soci\u00e9t\u00e9 a annonc\u00e9 qu'elle allait r\u00e9duire au minimum le nombre d'employ\u00e9s dans les laboratoires et faire en sorte que tous les employ\u00e9s travaillent \u00e0 domicile dans la mesure du possible.<\/p>\n<p>\u00c0 la lumi\u00e8re de la pand\u00e9mie, les entreprises de dispositifs m\u00e9dicaux peuvent trouver plus difficile d'acc\u00e9der aux comp\u00e9tences sp\u00e9cialis\u00e9es n\u00e9cessaires pour obtenir les marques CE pour les produits actuels, ou pour mettre de nouveaux produits sur le march\u00e9. Une fa\u00e7on d'acc\u00e9der \u00e0 des comp\u00e9tences sp\u00e9cialis\u00e9es pendant la pand\u00e9mie est de consulter un consultant ind\u00e9pendant exp\u00e9riment\u00e9 en mati\u00e8re de dispositifs m\u00e9dicaux, qui peut travailler \u00e0 distance sur des projets r\u00e9glementaires, d'essais cliniques ou de statistiques. Comment les consultants en dispositifs m\u00e9dicaux peuvent-ils aider \u00e0 distance ?<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_Regulatory_writing\"><\/span>1. R\u00e9daction de la r\u00e9glementation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Les fabricants qui ne disposent pas d\u00e9j\u00e0 d'un marquage CE pour leurs produits en vertu de la r\u00e9glementation sur les dispositifs m\u00e9dicaux (MDR) doivent en obtenir un afin de pouvoir vendre le dispositif dans l'UE lorsque la transition de l'actuelle directive sur les dispositifs m\u00e9dicaux (MDD) prendra fin en 2021.<\/p>\n<p>De m\u00eame, ceux qui mettent de nouveaux produits sur le march\u00e9 pour faire face \u00e0 la pand\u00e9mie auront besoin d'un acc\u00e8s rapide aux informations suivantes <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">consultants en affaires r\u00e9glementaires<\/a> Un ind\u00e9pendant peut aider \u00e0 compl\u00e9ter la documentation du dossier technique, comme les rapports d'\u00e9valuation clinique (CER), pour lesquels le RIM exige d\u00e9sormais beaucoup plus de d\u00e9tails.<\/p>\n<p>Les entreprises de dispositifs m\u00e9dicaux peuvent faire appel \u00e0 un freelance exp\u00e9riment\u00e9 dans la gestion de projets cliniques, la r\u00e9daction technique et ayant une connaissance approfondie du paysage r\u00e9glementaire, pour les aider dans cette t\u00e2che.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Verification_of_materials_for_new_PPE_or_equipment\"><\/span>2. V\u00e9rification des mat\u00e9riaux pour les nouveaux EPI ou \u00e9quipements<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>La pand\u00e9mie de COVID-19 a provoqu\u00e9 une p\u00e9nurie de masques et de blouses et de nombreuses institutions doivent r\u00e9utiliser du mat\u00e9riel. Les entreprises s'activent pour aider, par exemple, le fabricant de textiles techniques Milliken &amp; Company produit d\u00e9sormais des tissus de protection des barri\u00e8res critiques pour les blouses et les couvre-chefs.<\/p>\n<p>Avant que le personnel hospitalier puisse utiliser l'\u00e9quipement, ces nouvelles conceptions doivent \u00eatre v\u00e9rifi\u00e9es et les mat\u00e9riaux doivent \u00eatre contr\u00f4l\u00e9s quant \u00e0 leur s\u00e9curit\u00e9 et leur efficacit\u00e9.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Statistical_verification_for_clinical_trials\"><\/span><span style=\"font-size: 18px;\">3. V\u00e9rification statistique pour les essais cliniques<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Pour obtenir un marquage CE dans le cadre du RIM, les fabricants de produits existants peuvent \u00eatre amen\u00e9s \u00e0 r\u00e9aliser des essais cliniques suppl\u00e9mentaires. Les fabricants de nouveaux produits qui ont \u00e9t\u00e9 con\u00e7us pour contribuer \u00e0 l'effort COVID-19, peuvent \u00e9galement subir des pressions pour que les essais soient r\u00e9alis\u00e9s rapidement.<\/p>\n<p>L'analyse statistique des donn\u00e9es d'essais cliniques en dehors du laboratoire peut s'av\u00e9rer difficile car les fabricants peuvent manquer de puissance informatique et de logiciels n\u00e9cessaires lorsqu'ils travaillent \u00e0 domicile.<\/p>\n<p>Une fa\u00e7on de contourner ce d\u00e9fi est de recruter un <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">biostatisticien \u00e0 distance<\/a> ou un sp\u00e9cialiste similaire comp\u00e9tent dans la gestion des donn\u00e9es pour effectuer des t\u00e2ches telles que la compilation de fiches de donn\u00e9es ou la r\u00e9daction d'algorithmes pour votre \u00e9tude clinique. Ainsi, vous pouvez rester ma\u00eetre de vos donn\u00e9es et surveiller les effets de vos dispositifs.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Literature_searches\"><\/span>4. Recherche documentaire<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\/fr\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">recherche<\/a> papers or a medical database, such as MEDLINE.<\/p>\n<p>Elle peut \u00e9galement inclure des informations provenant de concurrents, par exemple si le fabricant tente de revendiquer l'\u00e9quivalence.<\/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=MDFreelancer\">consultant en recherche documentaire<\/a> est capable d'effectuer toutes les \u00e9tapes. En utilisant un protocole standardis\u00e9, ils peuvent \u00e9galement r\u00e9p\u00e9ter ces recherches lors des mises \u00e0 jour ult\u00e9rieures des REC. \u00c9tant donn\u00e9 que les REC ne seront plus un document statique dans le cadre du RIM et qu'elles devront \u00eatre p\u00e9riodiquement mises \u00e0 jour, cette approche est tourn\u00e9e vers l'avenir.<\/p>\n<p>Bien que le travail \u00e0 domicile soit d\u00e9sormais \"une n\u00e9cessit\u00e9\" pour de nombreux fabricants de dispositifs m\u00e9dicaux, il ne doit pas \u00eatre un obstacle.<\/p>\n<p><strong>Pr\u00eat \u00e0 embaucher <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">freelances sp\u00e9cialis\u00e9s dans les dispositifs m\u00e9dicaux<\/a>? Publiez gratuitement votre projet sur Kolabtree et obtenez des devis d'experts. <a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDFreelancer\">PUBLIER UN PROJET MAINTENANT<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>\u00c0 l'heure o\u00f9 la r\u00e9volution des freelances s'empare du monde, voici un aper\u00e7u de la mani\u00e8re dont l'embauche de freelances sp\u00e9cialis\u00e9s dans les dispositifs m\u00e9dicaux peut vous aider \u00e0 vous d\u00e9velopper rapidement et facilement. Oval Medical Technologies, une entreprise sp\u00e9cialis\u00e9e dans l'administration de m\u00e9dicaments, n'est qu'un exemple parmi d'autres d'une entreprise m\u00e9dicale passant au travail \u00e0 distance. L'entreprise a annonc\u00e9 qu'elle allait r\u00e9duire le nombre d'employ\u00e9s de l'entreprise.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-freelancers-how-can-remote-experts-help\/\" title=\"Lire la suite\">Lire la suite<\/a><\/div>","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, 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