{"id":4305,"date":"2023-06-20T14:00:38","date_gmt":"2023-06-20T06:00:38","guid":{"rendered":"https:\/\/regask.com\/?p=4305"},"modified":"2024-10-26T02:57:59","modified_gmt":"2024-10-25T18:57:59","slug":"software-del-reino-unido-como-dispositivo-medico","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-software-as-a-medical-device\/","title":{"rendered":"La MHRA del Reino Unido public\u00f3 una gu\u00eda sobre el software como dispositivo m\u00e9dico\u2026"},"content":{"rendered":"<div>\n<div>\n<div>\n<div><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener\">MHRA del Reino Unido<\/a> anunci\u00f3 el a\u00f1o pasado el Programa de Cambio de Software e IA como Dispositivo M\u00e9dico para garantizar que los requisitos regulatorios para el software y la IA sean claros y que los pacientes est\u00e9n protegidos.<\/div>\n<div><\/div>\n<div>La MHRA considera que una declaraci\u00f3n de prop\u00f3sito previsto inadecuada puede generar incumplimiento de la ley y posibles problemas de seguridad y, considerando la necesidad emergente de cumplimiento normativo en esta \u00e1rea, la MHRA public\u00f3 la gu\u00eda sobre el software como dispositivo m\u00e9dico.<\/div>\n<div><\/div>\n<div>La MHRA est\u00e1 intentando delinear algunas preocupaciones comunes con\u2026<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div><strong>Puede encontrar m\u00e1s detalles sobre este documento en la Plataforma RegASK.\u00a0<\/strong><\/div>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-837215826\" >\n    <div class=\"slider slider-nav-circle slider-nav-large slider-nav-dark slider-style-normal\"\n        data-flickity-options='{            \"cellAlign\": \"center\",            \"imagesLoaded\": true,            \"lazyLoad\": 1,            \"freeScroll\": false,            \"wrapAround\": true,            \"autoPlay\": 4500,            \"pauseAutoPlayOnHover\" : true,            \"prevNextButtons\": true,            \"contain\" : true,            \"adaptiveHeight\" : true,            \"dragThreshold\" : 10,            \"percentPosition\": true,            \"pageDots\": false,            \"rightToLeft\": false,            \"draggable\": true,            \"selectedAttraction\": 0.1,            \"parallax\" : 0,            \"friction\": 0.6        }'\n        >\n        \n     <\/div>\n\n     <div class=\"loading-spin dark large centered\"><\/div>\n\n\t<\/div>\n\n\n\t<div id=\"gap-1648069808\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1648069808 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_265665890\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-510377053\">\n\n\t<div id=\"col-1504233118\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_1764982632\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-934932310\">\n\n\n\t<div id=\"col-1440157449\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>Lo sentimos, este contenido premium es solo para clientes de RegASK.<\/h2>\n<p>\u00bfQuieres acceder a todo el contenido de la alerta o navegar por todas las noticias?\u00a0<\/p>\n<div class=\"row\"  id=\"row-795492358\">\n\n\n\t<div id=\"col-1108069498\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Inicio de sesi\u00f3n del cliente<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/solicitar-una-demostracion\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Navegar por las noticias<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1764982632 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_265665890 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-1982085463\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1982085463 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>La MHRA del Reino Unido anunci\u00f3 el a\u00f1o pasado el Programa de Cambio de Software e IA para Dispositivos M\u00e9dicos con el fin de garantizar la claridad de los requisitos regulatorios para el software y la IA y la protecci\u00f3n de los pacientes. La MHRA considera que una declaraci\u00f3n de prop\u00f3sito prevista inapropiada puede generar incumplimiento de la ley y posibles problemas de seguridad, y considerando la creciente necesidad de regulaciones\u2026<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[526,39],"tags":[40,56],"class_list":["post-4305","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-kingdom-regulations","category-medical-devices-insights","tag-latest-insights","tag-premium-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK: Software as a Medical Device | RegASK<\/title>\n<meta name=\"description\" content=\"The MHRA publishes guidance on software as a medical device. Stay informed on the latest regulations with RegASK.\" \/>\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\/es\/software-del-reino-unido-como-dispositivo-medico\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Published Guidance on Software as a Medical Devices\" \/>\n<meta property=\"og:description\" content=\"The MHRA publishes guidance on software as a medical device. Stay informed on the latest regulations with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/software-del-reino-unido-como-dispositivo-medico\/\" \/>\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=\"2023-06-20T06:00:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T18:57:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\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=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"UK MHRA Published Guidance on Software as a Medical Dev&hellip;\",\"datePublished\":\"2023-06-20T06:00:38+00:00\",\"dateModified\":\"2024-10-25T18:57:59+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/\"},\"wordCount\":130,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"keywords\":[\"Latest Insights\",\"Premium News\"],\"articleSection\":[\"United Kingdom\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/\",\"name\":\"UK: Software as a Medical Device | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"datePublished\":\"2023-06-20T06:00:38+00:00\",\"dateModified\":\"2024-10-25T18:57:59+00:00\",\"description\":\"The MHRA publishes guidance on software as a medical device. Stay informed on the latest regulations with RegASK.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/uk-software-as-a-medical-device\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"width\":689,\"height\":626,\"caption\":\"Brain Nervous System Medical Devices\"},{\"@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\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@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\\\/@RegASK\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Reino Unido: El software como dispositivo m\u00e9dico | RegASK","description":"La MHRA publica una gu\u00eda sobre el software como dispositivo m\u00e9dico. Mant\u00e9ngase informado sobre las \u00faltimas regulaciones con RegASK.","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\/es\/software-del-reino-unido-como-dispositivo-medico\/","og_locale":"es_ES","og_type":"article","og_title":"UK MHRA Published Guidance on Software as a Medical Devices","og_description":"The MHRA publishes guidance on software as a medical device. Stay informed on the latest regulations with RegASK.","og_url":"https:\/\/regask.com\/es\/software-del-reino-unido-como-dispositivo-medico\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-06-20T06:00:38+00:00","article_modified_time":"2024-10-25T18:57:59+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.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":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/#article","isPartOf":{"@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"UK MHRA Published Guidance on Software as a Medical Dev&hellip;","datePublished":"2023-06-20T06:00:38+00:00","dateModified":"2024-10-25T18:57:59+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/"},"wordCount":130,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","keywords":["Latest Insights","Premium News"],"articleSection":["United Kingdom","Medical Devices"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/","url":"https:\/\/regask.com\/uk-software-as-a-medical-device\/","name":"Reino Unido: El software como dispositivo m\u00e9dico | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","datePublished":"2023-06-20T06:00:38+00:00","dateModified":"2024-10-25T18:57:59+00:00","description":"La MHRA publica una gu\u00eda sobre el software como dispositivo m\u00e9dico. Mant\u00e9ngase informado sobre las \u00faltimas regulaciones con RegASK.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/uk-software-as-a-medical-device\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/uk-software-as-a-medical-device\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","width":689,"height":626,"caption":"Brain Nervous System Medical Devices"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Habilitando decisiones regulatorias m\u00e1s inteligentes","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":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@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\/@RegASK"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/4305","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=4305"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/4305\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/3003"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=4305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=4305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=4305"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}