{"id":12378,"date":"2021-02-05T09:44:28","date_gmt":"2021-02-05T15:44:28","guid":{"rendered":"https:\/\/saluddigital.com\/?p=12378"},"modified":"2025-10-21T13:04:43","modified_gmt":"2025-10-21T19:04:43","slug":"oxford-global-guidance-la-plataforma-digital-para-la-comprension-de-la-regulacion-de-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/plataformas-digitales\/oxford-global-guidance-la-plataforma-digital-para-la-comprension-de-la-regulacion-de-dispositivos-medicos\/","title":{"rendered":"Oxford Global Guidance the digital platform for understanding medical device regulation"},"content":{"rendered":"
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The University of Oxford created a digital platform aimed at personnel working in the area of medical devices and their development, to learn about and understand the regulations of various devices. \t<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The University of Oxford, through its Natural Interaction Laboratory (NIL) in the department of Engineering Science, has created a web-based digital tool aimed at people working around medical device development. The tool was funded by the Engineering and Physical Sciences Research Council (EPSRC) of the United Kingdom and the European Institute of Innovation and Technology (EIT), a European Union (EU) institution.<\/p>

Oxford Global Guidance is a digital tool to facilitate and streamline understanding of how medical device regulations apply to new products or products under development. On their website, they indicate that the tool was launched earlier than expected, as due to the COVID-19 pandemic, they sought to drive a functional platform for medical equipment personnel to navigate and learn about medical device regulations and requirements, specifically in the EU.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The platform is divided in four steps, first the online support for the description of the device; subsequently, the platform presents a questionnaire to evaluate whether or not it is a medical device according to EU regulations; the third step, the classification involves another questionnaire to find out to which classification the device belongs according to EU MDR and IVDR regulations; finally the result, will provide a more extensive overview for decision making with experts in healthcare institutions or for the improvement of the device in its development process.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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This process takes at least 20 minutes and is offered free of charge through a basic registration via an email address. It is currently in a process of continuous improvement, to add new features and better navigation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

OXFORD GLOBAL GUIDANCE <\/strong><\/p>

https:\/\/www.oxfordglobalguidance.com\/<\/a><\/p>

\u00a0<\/p>

BARCELONA HEALTH HUB <\/strong><\/p>

https:\/\/barcelonahealthhub.com\/blog\/2021\/01\/15\/oxford-global-guidance-helps-to-navigate-the-world-of-medical-device-regulation\/<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

La Universidad de Oxford cre\u00f3 una plataforma digital dirigida a personal que trabaja en el \u00e1rea de los dispositivos m\u00e9dicos y en su desarrollo, para conocer y entender las regulaciones de los diversos dispositivos. La Universidad de Oxford, a trav\u00e9s de su Laboratorio Interacci\u00f3n Natural (NIL) del departamento de Ciencias de la Ingenier\u00eda, ha creado una herramienta digital basada en una plataforma web, dirigida a personas que se desempe\u00f1an alrededor del desarrollo de dispositivos m\u00e9dicos. La herramienta fue impulsada con fondos del Consejo de Investigaci\u00f3n de Ingenier\u00eda y Ciencias F\u00edsicas (EPSRC), del Reino Unido y el Instituto Europeo de Innovaci\u00f3n y Tecnolog\u00eda (EIT) instituci\u00f3n perteneciente a la Uni\u00f3n Europea (UE). Oxford Global Guidance es una herramienta digital para facilitar y agilizar el entendimiento sobre c\u00f3mo se aplican las regulaciones de dispositivos m\u00e9dicos a los nuevos productos o a los productos en desarrollo. En su sitio web, indican que la herramienta fue lanzada antes de lo esperado, ya que debido a la pandemia por COVID-19, buscaron impulsar una plataforma funcional para que el personal encargado de equipo m\u00e9dico pudiera navegar y conocer las regulaciones y requisitos de los dispositivos m\u00e9dicos, espec\u00edficamente en la UE. La plataforma se divide en cuatro pasos, primero el soporte en l\u00ednea para la descripci\u00f3n del dispositivo; posteriormente, la plataforma presenta un cuestionario para evaluar si se trata o no de un dispositivo m\u00e9dico de acuerdo a las regulaciones de la UE; el tercer paso, la clasificaci\u00f3n involucra otro cuestionario para averiguar a qu\u00e9 clasificaci\u00f3n pertenece el dispositivo de acuerdo a las regulaciones MDR e IVDR de la UE; finalmente el resultado, brindar\u00e1 un panorama m\u00e1s extenso para la toma de decisiones con expertos en las instituciones de salud o para la mejora del dispositivo en su proceso de desarrollo. Este proceso tarda al menos 20 minutos y es ofrecido de forma gratuita a trav\u00e9s de un registro b\u00e1sico mediante una direcci\u00f3n de correo electr\u00f3nico. Actualmente se encuentra en un proceso de mejoras contante, para a\u00f1adir nuevas caracter\u00edsticas y una mejor navegaci\u00f3n. BIBLIOGRAF\u00cdA OXFORD GLOBAL GUIDANCE https:\/\/www.oxfordglobalguidance.com\/ \u00a0 BARCELONA HEALTH HUB https:\/\/barcelonahealthhub.com\/blog\/2021\/01\/15\/oxford-global-guidance-helps-to-navigate-the-world-of-medical-device-regulation\/<\/p>","protected":false},"author":1,"featured_media":12379,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,153],"tags":[145],"class_list":["post-12378","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-plataformas-digitales","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/12378","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=12378"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/12378\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/12379"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=12378"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=12378"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=12378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}