{"id":4109,"date":"2023-01-31T16:13:16","date_gmt":"2023-01-31T08:13:16","guid":{"rendered":"https:\/\/regask.com\/?p=4109"},"modified":"2024-11-22T05:16:28","modified_gmt":"2024-11-21T21:16:28","slug":"commercialisez-votre-samd-en-toute-confiance-et-en-toute-conformite","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/bring-your-samd-to-market-with-confidence-and-compliance\/","title":{"rendered":"Mettre le SaMD sur le march\u00e9 en toute confiance et en toute conformit\u00e9"},"content":{"rendered":"<p>La sant\u00e9 num\u00e9rique est un domaine \u00e9mergent qui r\u00e9volutionne la mani\u00e8re dont les soins de sant\u00e9 sont dispens\u00e9s. Elle combine technologie, donn\u00e9es et analyses pour am\u00e9liorer les diagnostics, les traitements et les r\u00e9sultats des patients. Le logiciel en tant que dispositif m\u00e9dical (SaMD), en tant que sous-secteur des solutions de sant\u00e9 num\u00e9rique, conna\u00eet une croissance rapide, tant en termes d&#039;\u00e9chelle industrielle que d&#039;innovations.<\/p>\n<p>Avec de plus en plus <a href=\"https:\/\/regask.com\/fr\/comment-reglementer-les-diagnostics-numeriques-samd-nous-eu\/\">SaMD<\/a> En cours de d\u00e9ploiement, les r\u00e9glementations dans ce domaine sont devenues de plus en plus complexes, avec davantage d&#039;exigences r\u00e9glementaires et de plus grandes variations selon les pays. Le lancement d&#039;un nouveau produit SaMD peut \u00eatre une t\u00e2che ardue. La cl\u00e9 du succ\u00e8s commercial est la conformit\u00e9 r\u00e9glementaire. Cependant, avec la bonne <a href=\"https:\/\/regask.com\/fr\/comment-creer-une-strategie-reglementaire-gagnante-pour-votre-entreprise\/\" target=\"_blank\" rel=\"noopener\">strat\u00e9gie r\u00e9glementaire<\/a> une fois ces mesures mises en place, les entreprises peuvent aligner leur strat\u00e9gie commerciale et leurs activit\u00e9s r\u00e9glementaires pour assurer la conformit\u00e9 des produits et le succ\u00e8s de leur mise sur le march\u00e9.<\/p>\n<p>Il est donc essentiel que les fabricants de SaMD comprennent <a href=\"https:\/\/regask.com\/fr\/when-does-your-app-become-a-medical-device\/\" target=\"_blank\" rel=\"noopener\">Comment les logiciels sont r\u00e9glement\u00e9s en tant que dispositifs m\u00e9dicaux<\/a> afin de d\u00e9velopper une strat\u00e9gie r\u00e9glementaire forte et efficace.<\/p>\n<p>S&#039;appuyant sur notre solide expertise du domaine et sur plus de 20 ans d&#039;exp\u00e9rience en conseil, RegASK a fait ses preuves en aidant les fabricants de SaMD dans leurs parcours r\u00e9glementaires et leur r\u00e9ussite commerciale.<\/p>\n<p><strong>De la classification et de l&#039;enregistrement des produits \u00e0 la commercialisation, lisez l&#039;\u00e9tude de cas pour savoir comment RegASK a aid\u00e9 une entreprise de sant\u00e9 num\u00e9rique \u00e0 \u00e9laborer une strat\u00e9gie r\u00e9glementaire optimale en Asie.<\/strong><\/p>\n<h2 class=\"h4\"><strong>Objectif<\/strong><\/h2>\n<p>Un fournisseur mondial de premier plan de soins de sant\u00e9 mentale num\u00e9riques a d\u00e9velopp\u00e9 une application qui propose une th\u00e9rapie cognitivo-comportementale (TCC) aux patients souffrant de divers troubles. Le client souhaite lancer l&#039;application dans quelques pays asiatiques, dont Hong Kong, la Malaisie et la Tha\u00eflande.<\/p>\n<p>Le client souhaitait savoir s&#039;il pouvait commercialiser son application et s&#039;il existait des restrictions sur les march\u00e9s cibles. Pour atteindre son objectif, le client a fait appel \u00e0 RegASK pour son <a href=\"https:\/\/regask.com\/fr\/our-solution\/#monitor\" target=\"_blank\" rel=\"noopener\">service de consultation en affaires r\u00e9glementaires<\/a>.<\/p>\n<h2 class=\"h4\"><strong>Solution<\/strong><\/h2>\n<ul>\n<li>Identifi\u00e9 le cadre r\u00e9glementaire applicable au SaMD \u00e0 Hong Kong, en Malaisie et en Tha\u00eflande\u00a0;<\/li>\n<li>D\u00e9finition des pays qui n\u00e9cessitent l&#039;enregistrement du produit du client et du processus d&#039;enregistrement ;<\/li>\n<li>Analyser si le produit doit \u00eatre class\u00e9 comme dispositif m\u00e9dical en vertu de la r\u00e9glementation en vigueur\u00a0;<\/li>\n<li>\u00c9valuer les possibilit\u00e9s de lancement du logiciel du client sur les march\u00e9s cibles et de le commercialiser selon le mod\u00e8le pr\u00e9f\u00e9r\u00e9 du client.<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>R\u00e9sultats<\/strong><\/h2>\n<p>Gr\u00e2ce \u00e0 l\u2019expertise de RegASK, le client a re\u00e7u des informations cruciales pour d\u00e9terminer la voie r\u00e9glementaire la plus appropri\u00e9e pour le lancement de son produit SaMD sur les march\u00e9s cibles.<\/p>\n<p>L\u2019examen et l\u2019\u00e9valuation r\u00e9glementaires r\u00e9alis\u00e9s par RegASK ont aid\u00e9 le client \u00e0 \u00e9conomiser des centaines d\u2019heures de recherche de r\u00e9glementations et \u00e0 concevoir une strat\u00e9gie r\u00e9glementaire optimale pour maximiser ses chances de succ\u00e8s.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Lire plus d&#039;\u00e9tudes de cas sur les dispositifs m\u00e9dicaux<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is experiencing fast growth in both industry scale and innovations. With more and more SaMD being rolled out, regulations&#8230;<\/p>","protected":false},"author":39,"featured_media":4108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22,535],"tags":[],"class_list":["post-4109","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices","category-thailand-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bringing SaMD to Market with Confidence and Compliance | RegASK<\/title>\n<meta name=\"description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/commercialisez-votre-samd-en-toute-confiance-et-en-toute-conformite\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bringing SaMD to Market with Confidence and Compliance\" \/>\n<meta property=\"og:description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/commercialisez-votre-samd-en-toute-confiance-et-en-toute-conformite\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-31T08:13:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T21:16:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Bringing SaMD to Market with Confidence and Compliance\",\"datePublished\":\"2023-01-31T08:13:16+00:00\",\"dateModified\":\"2024-11-21T21:16:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"},\"wordCount\":427,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"articleSection\":[\"Case Studies\",\"Medical Devices\",\"Thailand\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\",\"name\":\"Bringing SaMD to Market with Confidence and Compliance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"datePublished\":\"2023-01-31T08:13:16+00:00\",\"dateModified\":\"2024-11-21T21:16:28+00:00\",\"description\":\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/01\\\/bring-your-samd-to-market-with-confidence-and-compliance.png\",\"width\":1600,\"height\":1200,\"caption\":\"Bringing Your Samd To Market With Confidence And Compliance\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Commercialiser le SaMD en toute confiance et en toute conformit\u00e9 | RegASK","description":"Lisez l\u2019\u00e9tude de cas pour savoir comment RegASK a aid\u00e9 une entreprise de sant\u00e9 num\u00e9rique \u00e0 lancer son produit SaMD sur plusieurs march\u00e9s.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/commercialisez-votre-samd-en-toute-confiance-et-en-toute-conformite\/","og_locale":"fr_FR","og_type":"article","og_title":"Bringing SaMD to Market with Confidence and Compliance","og_description":"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.","og_url":"https:\/\/regask.com\/fr\/commercialisez-votre-samd-en-toute-confiance-et-en-toute-conformite\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-01-31T08:13:16+00:00","article_modified_time":"2024-11-21T21:16:28+00:00","og_image":[{"width":1600,"height":1200,"url":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#article","isPartOf":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"Bringing SaMD to Market with Confidence and Compliance","datePublished":"2023-01-31T08:13:16+00:00","dateModified":"2024-11-21T21:16:28+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"},"wordCount":427,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","articleSection":["Case Studies","Medical Devices","Thailand"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/","url":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/","name":"Commercialiser le SaMD en toute confiance et en toute conformit\u00e9 | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","datePublished":"2023-01-31T08:13:16+00:00","dateModified":"2024-11-21T21:16:28+00:00","description":"Lisez l\u2019\u00e9tude de cas pour savoir comment RegASK a aid\u00e9 une entreprise de sant\u00e9 num\u00e9rique \u00e0 lancer son produit SaMD sur plusieurs march\u00e9s.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/bring-your-samd-to-market-with-confidence-and-compliance\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png","width":1600,"height":1200,"caption":"Bringing Your Samd To Market With Confidence And Compliance"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Favoriser des d\u00e9cisions r\u00e9glementaires plus intelligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Beno\u00eet Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/4109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=4109"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/4109\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/4108"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=4109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=4109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=4109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}