{"id":8428,"date":"2025-09-28T19:43:39","date_gmt":"2025-09-28T19:43:39","guid":{"rendered":"https:\/\/mdxcro.com\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/"},"modified":"2026-04-07T07:52:45","modified_gmt":"2026-04-07T07:52:45","slug":"una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/","title":{"rendered":"Una gu\u00eda paso a paso de la norma IEC 62366 y la ingenier\u00eda de la usabilidad"},"content":{"rendered":"\n<p>La <a href=\"https:\/\/mdxcro.com\/es\/servicios\/ingenieria-de-la-usabilidad\/\">\n  <strong>usabilidad de los dispositivos m\u00e9dicos<\/strong>\n<\/a> no es solo una cuesti\u00f3n de comodidad. Es una cuesti\u00f3n de seguridad, eficacia y cumplimiento normativo. Un dise\u00f1o deficiente que confunde o frustra a los usuarios puede provocar errores de uso, efectos adversos e incluso da\u00f1os al paciente. Para abordar esto, la norma internacional <a href=\"https:\/\/www.iso.org\/standard\/63179.html\">\n  <strong>IEC 62366-1:2015\/Amd 1:2020<\/strong>\n<\/a> establece un marco estructurado para la ingenier\u00eda de la usabilidad en el desarrollo de dispositivos m\u00e9dicos.   <\/p>\n\n<p>Para los fabricantes de dispositivos m\u00e9dicos, es esencial comprender y aplicar la norma IEC 62366. El cumplimiento demuestra que los riesgos de usabilidad se han identificado, reducido y documentado, lo cual es esencial para todos los <a href=\"https:\/\/mdxcro.com\/es\/sectors\/dispositivos-medicos\/\">\n  <strong>dispositivos m\u00e9dicos<\/strong>\n<\/a>, incluidos los <strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/sectors\/servicios-integrales-para-div\/\">DIV<\/a>\n<\/strong> y el <a href=\"https:\/\/mdxcro.com\/resources-sector\/digital-health-ai\/\">\n  <strong>Software como dispositivo m\u00e9dico (SaMD)<\/strong>\n<\/a>. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfQu\u00e9 es la norma IEC 62366?<\/strong><\/h2>\n\n<p>La norma IEC 62366 es la norma reconocida internacionalmente que define c\u00f3mo integrar la usabilidad en el proceso de dise\u00f1o y desarrollo.<\/p>\n\n<p>Tiene dos partes principales:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>IEC 62366-1:2015\/Amd 1:2020<\/strong> <em>Dispositivos m\u00e9dicos \u2013 Aplicaci\u00f3n de la ingenier\u00eda de la usabilidad a los dispositivos m\u00e9dicos<\/em>: La norma principal que describe el proceso de ingenier\u00eda de la usabilidad.<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li><strong>IEC\/TR 62366-2:2016<\/strong> <em>Dispositivos m\u00e9dicos \u2013 Gu\u00eda sobre la aplicaci\u00f3n de la ingenier\u00eda de la usabilidad a los dispositivos m\u00e9dicos<\/em>: Un informe t\u00e9cnico que proporciona orientaci\u00f3n y ejemplos para apoyar la implementaci\u00f3n.<\/li>\n<\/ul>\n\n<p>El objetivo es garantizar que la ingenier\u00eda de la usabilidad se aplique de manera coherente para que los dispositivos puedan ser utilizados de forma segura y eficaz por los usuarios previstos, en los entornos de uso previstos, al tiempo que se garantiza que los errores de uso que podr\u00edan causar da\u00f1os se identifiquen, reduzcan y controlen mediante actividades de usabilidad estructuradas.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Por qu\u00e9 es importante la ingenier\u00eda de la usabilidad<\/strong><\/h2>\n\n<p>Los <strong>errores relacionados con el uso<\/strong> son una de las principales causas de efectos adversos relacionados con los dispositivos. Al integrar la ingenier\u00eda de la usabilidad en el desarrollo de productos, los fabricantes pueden: <\/p>\n\n<ul class=\"wp-block-list\">\n<li>Reducir los errores de uso que podr\u00edan causar da\u00f1os<\/li>\n\n\n\n<li>Mejorar la seguridad del paciente y los resultados del tratamiento<\/li>\n\n\n\n<li>Satisfacer los requisitos reglamentarios de MDR, IVDR y la FDA<\/li>\n\n\n\n<li>Aumentar la aceptaci\u00f3n del usuario y el \u00e9xito en el mercado<\/li>\n\n\n\n<li>Reducir los costes a largo plazo evitando redise\u00f1os o retiradas<\/li>\n<\/ul>\n\n<p>En resumen, la usabilidad es tanto un requisito de cumplimiento como una ventaja competitiva.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Gu\u00eda paso a paso para aplicar la norma IEC 62366<\/strong><\/h2>\n\n<p>The usability engineering process defined in IEC 62366 is systematic and iterative. It integrates into the overall product development lifecycle and risk management process in line with <a href=\"https:\/\/mdxcro.com\/sectors\/iso-standards\/\" type=\"sector\" id=\"10197\">ISO 14971.<\/a> Below is a step-by-step breakdown.<\/p>\n\n<figure class=\"wp-block-image size-medium is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"481\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-1200x481.png\" alt=\"Gu&#xED;a visual paso a paso que ilustra el proceso de ingenier&#xED;a de la usabilidad IEC 62366 para dispositivos m&#xE9;dicos, que abarca la definici&#xF3;n del uso previsto, la identificaci&#xF3;n de peligros, el an&#xE1;lisis de riesgos, los requisitos de la interfaz de usuario, las evaluaciones formativas y la validaci&#xF3;n sumativa de la usabilidad, en consonancia con las directrices de factores humanos de la UE MDR y la FDA.\" class=\"wp-image-8130\" style=\"aspect-ratio:2.494885711303622;width:903px;height:auto\" title=\"Proceso de ingenier&#xED;a de la usabilidad IEC 62366 para dispositivos m&#xE9;dicos: gu&#xED;a visual paso a paso\" srcset=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-1200x481.png 1200w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-1600x642.png 1600w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-768x308.png 768w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-1536x616.png 1536w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Step-by-Step-Guide-to-IEC-62366-2048x821.png 2048w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/figure>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-b4c6c36cd751d82e2960006dfd4d21d7\"><strong>1. Establecer el archivo de ingenier\u00eda de la usabilidad (UEF)<\/strong><\/h3>\n\n<p>El <strong>UEF<\/strong> es el <strong>repositorio central de documentaci\u00f3n para todas las actividades de usabilidad<\/strong>. Incluye el uso previsto, los perfiles de usuario, los escenarios de uso, el an\u00e1lisis de riesgos, los resultados de las pruebas y las medidas de control de riesgos. En la pr\u00e1ctica, los registros y otros documentos que forman el UEF tambi\u00e9n pueden formar parte del archivo de dise\u00f1o del producto (ISO 13485) o del archivo de <a href=\"https:\/\/mdxcro.com\/es\/servicios\/calidad-riesgo-auditoria\/\">\n  <strong>gesti\u00f3n de riesgos<\/strong>\n<\/a> (ISO 14971).  <\/p>\n\n<p>Piense en el UEF como una herramienta de gesti\u00f3n de proyectos y como prueba para los reguladores.<\/p>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-156168e41939e19a8fd2e42763852fd2\"><strong>2. Investigaci\u00f3n de usuarios<\/strong><\/h3>\n\n<p>Prepare la <strong>Especificaci\u00f3n de uso<\/strong>. Aqu\u00ed es donde se define: <\/p>\n\n<ul class=\"wp-block-list\">\n<li>El prop\u00f3sito m\u00e9dico previsto del dispositivo<\/li>\n\n\n\n<li>Los grupos de usuarios (por ejemplo, m\u00e9dicos, pacientes, legos, cuidadores)<\/li>\n\n\n\n<li>Los entornos de uso (hospitales, hogares, ambulancias, cl\u00ednicas)<\/li>\n\n\n\n<li>Cualquier formaci\u00f3n o experiencia requerida<\/li>\n<\/ul>\n\n<p>Esto constituye la base de todas las actividades de usabilidad posteriores.<\/p>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-9d1e848762230d4465fb5e07b2e3975f\"><strong>3. An\u00e1lisis<\/strong><\/h3>\n\n<p>Una vez que sepa qui\u00e9n va a utilizar su dispositivo y d\u00f3nde, el siguiente paso es analizar c\u00f3mo podr\u00edan salir mal las cosas.<\/p>\n\n<p>Las actividades incluyen:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Identificar las caracter\u00edsticas de la <strong>interfaz de usuario relacionadas con la seguridad<\/strong> (por ejemplo, la legibilidad de las pantallas, la disposici\u00f3n de los botones, la visibilidad de las alarmas).<\/li>\n\n\n\n<li>Revisar los <strong>datos posteriores a la producci\u00f3n y las bases de datos p\u00fablicas<\/strong> para detectar problemas de usabilidad conocidos con dispositivos similares.<\/li>\n\n\n\n<li>Identificar los <strong>peligros<\/strong> y las situaciones peligrosas.<\/li>\n\n\n\n<li>Identificar y describir los <strong>escenarios de uso relacionados con los peligros<\/strong>, que describen exactamente c\u00f3mo podr\u00edan producirse errores de uso y qu\u00e9 consecuencias podr\u00edan tener.<\/li>\n\n\n\n<li>Seleccionar escenarios de uso relacionados con los peligros para la <strong>evaluaci\u00f3n sumativa<\/strong>.<\/li>\n<\/ul>\n\n<p>Estos escenarios se priorizan para decidir cu\u00e1les se evaluar\u00e1n en las pruebas sumativas.<\/p>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-5332f5533742b65f7e17951ef08dd942\"><strong>4. Dise\u00f1o y evaluaci\u00f3n formativa<\/strong><\/h3>\n\n<p>Aqu\u00ed es donde el dise\u00f1o y las pruebas de usabilidad se realizan en ciclos iterativos.<\/p>\n\n<p>Pasos clave:<\/p>\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Establecer la especificaci\u00f3n de la interfaz de usuario<\/strong>: el plano de todos los elementos de la interfaz de usuario.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Desarrollar el plan de evaluaci\u00f3n de la interfaz de usuario<\/strong>: definir c\u00f3mo se realizar\u00e1n las pruebas formativas y sumativas.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Ciclos iterativos de concepto, prototipo y pruebas<\/strong><\/li>\n<\/ol>\n\n<p>El objetivo de la evaluaci\u00f3n formativa es encontrar problemas de usabilidad de forma temprana, antes de la validaci\u00f3n final, para que los cambios sean m\u00e1s baratos y menos disruptivos.<\/p>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-670633585025127bb190fe510b33e07b\"><strong>5. Evaluaci\u00f3n sumativa<\/strong><\/h3>\n\n<p>La etapa final es una <strong>validaci\u00f3n sumativa de la usabilidad<\/strong>. Se trata de una prueba formal que demuestra a los reguladores que el dispositivo puede ser utilizado de forma segura y eficaz por los usuarios previstos. <\/p>\n\n<ul class=\"wp-block-list\">\n<li>Probar los escenarios de uso relacionados con los peligros identificados anteriormente.<\/li>\n\n\n\n<li>Utilizar usuarios representativos en entornos realistas.<\/li>\n\n\n\n<li>Recopilar datos objetivos de rendimiento (finalizaci\u00f3n de tareas, tasas de error) y comentarios subjetivos (facilidad de uso, confianza).<\/li>\n\n\n\n<li>Confirmar que los riesgos residuales son aceptables de acuerdo con la norma ISO 14971.<\/li>\n<\/ul>\n\n<p>Esta etapa proporciona la evidencia objetiva que los reguladores requieren para garantizar el cumplimiento.<\/p>\n\n<h3 class=\"wp-block-heading has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-e911247f1cf9657316c172e846aca550\"><strong>6. Mantener la usabilidad despu\u00e9s de la comercializaci\u00f3n<\/strong><\/h3>\n\n<p>La ingenier\u00eda de la usabilidad no termina con el lanzamiento del producto. La <strong>vigilancia posterior a la comercializaci\u00f3n<\/strong> debe recopilar comentarios sobre problemas de usabilidad, efectos adversos y reclamaciones. Es posible que se requieran actualizaciones o cambios de dise\u00f1o si surgen nuevos riesgos. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Retos comunes en la aplicaci\u00f3n de la norma IEC 62366<\/strong><\/h2>\n\n<p>Muchos fabricantes se encuentran con dificultades como:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Subestimar los <strong>recursos<\/strong> necesarios para las pruebas de usabilidad<\/li>\n\n\n\n<li>Reclutar <strong>usuarios representativos<\/strong> para estudios formativos y de validaci\u00f3n<\/li>\n\n\n\n<li>Definir <strong>escenarios de uso realistas<\/strong> que reflejen los entornos cl\u00ednicos reales<\/li>\n\n\n\n<li>Integrar la usabilidad con los <strong>plazos de desarrollo<\/strong><\/li>\n\n\n\n<li><strong>Documentar<\/strong> correctamente las pruebas en el UEF<\/li>\n<\/ul>\n\n<p>No abordar estos retos puede resultar en el rechazo reglamentario, retrasos o redise\u00f1os costosos.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Buenas pr\u00e1cticas para el \u00e9xito<\/strong><\/h2>\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Comenzar la ingenier\u00eda de la usabilidad pronto<\/strong> en el proceso de dise\u00f1o<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Involucrar a <strong>equipos multidisciplinares<\/strong> que incluyan ingenieros, m\u00e9dicos y expertos en usabilidad<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Utilizar una mezcla de <strong>m\u00e9todos cualitativos y cuantitativos<\/strong> en las evaluaciones<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Priorizar los escenarios de uso relacionados con los peligros<\/strong> en las pruebas de validaci\u00f3n<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\"><strong>Documentar todo<\/strong> a fondo en el archivo de ingenier\u00eda de la usabilidad<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Siempre que sea posible, <strong>involucrar a los reguladores<\/strong> pronto para la alineaci\u00f3n<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Aprovechar la <strong>experiencia especializada<\/strong>, como la de una consultor\u00eda de dispositivos m\u00e9dicos y DIV con experiencia en ingenier\u00eda de la usabilidad<\/li>\n<\/ol>\n\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-blue-color has-text-color has-link-color wp-elements-cb4de69fd2a2a37831c66b598615b458\"><strong>Preguntas frecuentes<\/strong><\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1771401403973\"><strong class=\"schema-faq-question\"><strong>Does the FDA also recognise IEC 62366?<\/strong><\/strong> <p class=\"schema-faq-answer\">Yes. The latest versions of the IEC 62366 standards are recognised by the FDA as consensus standards. However, the FDA has also published <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/applying-human-factors-and-usability-engineering-medical-devices\"><strong>specific human factors engineering guidances<\/strong><\/a> with minor differences to IEC 62366 so it is recommended that these are also considered for FDA submissions<strong>.<\/strong><\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771401416061\"><strong class=\"schema-faq-question\"><strong>When should usability testing be performed?<\/strong><\/strong> <p class=\"schema-faq-answer\">Throughout development. Formative evaluations identify and correct issues early, while summative validation confirms safe and effective use before market approval.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771401429130\"><strong class=\"schema-faq-question\"><strong>Can simulated environments be accepted in usability validation?<\/strong><\/strong> <p class=\"schema-faq-answer\">Yes, provided they are representative of real-world conditions and cover all critical tasks and hazard-related use scenarios.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1773051080932\"><strong class=\"schema-faq-question\">What is the difference between IEC 62366-1 and IEC 62366-2?<\/strong> <p class=\"schema-faq-answer\">EC 62366-1 is the main normative standard that defines the usability engineering process manufacturers must follow. IEC 62366-2 is a companion informative document that provides guidance and rationale to help apply IEC 62366-1 in practice. For regulatory submissions, compliance with IEC 62366-1 is what notified bodies and regulators assess \u2014 IEC 62366-2 is a supporting resource, not a requirement.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1773051090167\"><strong class=\"schema-faq-question\"><strong>What must be included in a Usability Engineering File?<\/strong><\/strong> <p class=\"schema-faq-answer\">The Usability Engineering File (UEF) is the core documentation output of the IEC 62366-1 process. It must document the intended use and user groups, use scenarios and user interface specification, formative evaluation records, summative evaluation plan and results, and risk-related findings and how they were addressed. It should be structured to allow a notified body or regulatory reviewer to trace the full usability engineering process from start to finish.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1773051105497\"><strong class=\"schema-faq-question\">Does IEC 62366 apply to IVDs?<\/strong> <p class=\"schema-faq-answer\">Yes. IEC 62366-1 applies to all medical devices, including in vitro diagnostic devices (IVDs). Under the EU IVDR and MDR, manufacturers are expected to demonstrate that human factors and usability have been considered as part of the design and development process. This is particularly relevant for IVDs used at the point of care or by lay users, where use errors can have direct patient safety implications.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1773051121891\"><strong class=\"schema-faq-question\"><strong>How many participants are needed for a summative usability study?<\/strong><\/strong> <p class=\"schema-faq-answer\">There is no fixed number mandated by IEC 62366-1, but common practice \u2014 and FDA guidance \u2014 typically expects a minimum of 15 participants per user group for summative evaluations. The number should be justified based on the diversity of the user population, the complexity of the device, and the number of critical tasks being evaluated. For high-risk devices or large user populations, a larger sample may be required.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1773051138324\"><strong class=\"schema-faq-question\">What is the difference between a formative and summative evaluation?<\/strong> <p class=\"schema-faq-answer\">Formative evaluations are iterative assessments carried out during device development to identify and resolve usability problems early. They are exploratory in nature and do not need to meet a pre-defined pass\/fail criterion. Summative evaluations, also called validation testing, are conducted on a near-final or final version of the device to confirm that users can operate it safely and effectively without being coached or corrected. Summative results are what get submitted to regulators.<\/p> <\/div> <\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\"><strong>C\u00f3mo puede ayudar MDx CRO<\/strong><\/h2>\n\n<p>La implementaci\u00f3n interna de la norma IEC 62366 puede sobrecargar los recursos. En <strong>MDx CRO<\/strong> podemos proporcionar: <\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Desarrollo de protocolos y dise\u00f1o de estudios<\/strong> para pruebas de usabilidad<\/li>\n\n\n\n<li><strong>Reclutamiento de usuarios representativos<\/strong> en todas las geograf\u00edas<\/li>\n\n\n\n<li><strong>Moderaci\u00f3n<\/strong> de estudios formativos y de validaci\u00f3n<\/li>\n\n\n\n<li><strong>Integraci\u00f3n de la ingenier\u00eda de la usabilidad con la estrategia reguladora<\/strong><\/li>\n\n\n\n<li><strong>Preparaci\u00f3n de toda la documentaci\u00f3n de usabilidad<\/strong> necesaria para las presentaciones, incluidas las presentaciones a la FDA<\/li>\n<\/ul>\n\n<p>Como consultor\u00eda de confianza en dispositivos m\u00e9dicos y DIV, apoyamos a los fabricantes en la implementaci\u00f3n de la norma IEC 62366, la realizaci\u00f3n de estudios de usabilidad y la preparaci\u00f3n de documentaci\u00f3n que satisfaga a los reguladores de la UE y de EE. UU. Tanto si est\u00e1 iniciando un nuevo proyecto como si est\u00e1 actualizando un dispositivo existente, <a href=\"https:\/\/mdxcro.com\/es\/?page_id=8396\">nuestro equipo<\/a> le ayuda a lograr el cumplimiento y a ofrecer dispositivos m\u00e1s seguros al mercado. <\/p>\n\n<div class=\"wp-block-group is-nowrap is-layout-flex wp-container-core-group-is-layout-6c531013 wp-block-group-is-layout-flex\">\n<p>Request our <a href=\"https:\/\/mdxcro.com\/services\/usability-engineering\/\" type=\"service\" id=\"650\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Usability engineering services for medical devices and IVDs<\/mark><\/a>.<\/p>\n<\/div>\n\n<div style=\"height:100px;width:0px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\">Need help with IEC 62366 compliance? <\/h2>\n\n<p>Talk to our usability engineering team.<\/p>\n<style 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Es una cuesti\u00f3n de seguridad, eficacia y cumplimiento normativo. Un dise\u00f1o deficiente que confunde o frustra a los usuarios puede provocar errores de uso, efectos adversos e incluso da\u00f1os al paciente. Para abordar esto, la norma internacional IEC 62366-1:2015\/Amd 1:2020 establece un [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":6348,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[216],"tags":[],"resources-sector":[181,178,180],"class_list":["post-8428","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","resources-sector-digital-health-ai","resources-sector-ivds","resources-sector-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Una gu\u00eda paso a paso de la norma IEC 62366 y la ingenier\u00eda de la usabilidad - MDx CRO<\/title>\n<meta name=\"description\" content=\"Una gu\u00eda completa de la ingenier\u00eda de la usabilidad IEC 62366 para dispositivos m\u00e9dicos y DIV. Aprenda a implementar cada fase, desde el establecimiento de un archivo de ingenier\u00eda de la usabilidad hasta la realizaci\u00f3n de evaluaciones sumativas, para cumplir con MDR, IVDR y la normativa de la FDA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Una gu\u00eda paso a paso de la norma IEC 62366 y la ingenier\u00eda de la usabilidad - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Una gu\u00eda completa de la ingenier\u00eda de la usabilidad IEC 62366 para dispositivos m\u00e9dicos y DIV. Aprenda a implementar cada fase, desde el establecimiento de un archivo de ingenier\u00eda de la usabilidad hasta la realizaci\u00f3n de evaluaciones sumativas, para cumplir con MDR, IVDR y la normativa de la FDA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-28T19:43:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-07T07:52:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/77972596e95d42dd0816cba2df70f9b4241dd87f-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1280\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Carlos Galamba\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Carlos Galamba\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/\"},\"author\":{\"name\":\"Carlos Galamba\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#\\\/schema\\\/person\\\/757ac74b94d37b0b3992676bb7e868e4\"},\"headline\":\"Una gu\u00eda paso a paso de la norma IEC 62366 y la ingenier\u00eda de la usabilidad\",\"datePublished\":\"2025-09-28T19:43:39+00:00\",\"dateModified\":\"2026-04-07T07:52:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/\"},\"wordCount\":1899,\"publisher\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/77972596e95d42dd0816cba2df70f9b4241dd87f-scaled.jpg\",\"articleSection\":[\"blog\"],\"inLanguage\":\"es\"},{\"@type\":[\"WebPage\",\"FAQPage\"],\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/\",\"name\":\"Una gu\u00eda paso a paso de la norma IEC 62366 y la ingenier\u00eda de la usabilidad - MDx CRO\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/77972596e95d42dd0816cba2df70f9b4241dd87f-scaled.jpg\",\"datePublished\":\"2025-09-28T19:43:39+00:00\",\"dateModified\":\"2026-04-07T07:52:45+00:00\",\"description\":\"Una gu\u00eda completa de la ingenier\u00eda de la usabilidad IEC 62366 para dispositivos m\u00e9dicos y DIV. 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Their work spans Class C\/D IVDs, companion diagnostics, NGS-based assays, and software-based IVDs, with a current advisory role to the European Commission on regulatory matters. At MDx CRO, they lead regulatory strategy for complex IVD programs across EU IVDR, FDA, and global markets.","sameAs":["https:\/\/www.linkedin.com\/in\/carlos-galamba\/","https:\/\/www.youtube.com\/@MDxCRO"]},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401403973","position":1,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401403973","name":"Does the FDA also recognise IEC 62366?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Yes. The latest versions of the IEC 62366 standards are recognised by the FDA as consensus standards. However, the FDA has also published <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/applying-human-factors-and-usability-engineering-medical-devices\"><strong>specific human factors engineering guidances<\/strong><\/a> with minor differences to IEC 62366 so it is recommended that these are also considered for FDA submissions<strong>.<\/strong>","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401416061","position":2,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401416061","name":"When should usability testing be performed?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Throughout development. Formative evaluations identify and correct issues early, while summative validation confirms safe and effective use before market approval.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401429130","position":3,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1771401429130","name":"Can simulated environments be accepted in usability validation?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Yes, provided they are representative of real-world conditions and cover all critical tasks and hazard-related use scenarios.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051080932","position":4,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051080932","name":"What is the difference between IEC 62366-1 and IEC 62366-2?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"EC 62366-1 is the main normative standard that defines the usability engineering process manufacturers must follow. IEC 62366-2 is a companion informative document that provides guidance and rationale to help apply IEC 62366-1 in practice. For regulatory submissions, compliance with IEC 62366-1 is what notified bodies and regulators assess \u2014 IEC 62366-2 is a supporting resource, not a requirement.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051090167","position":5,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051090167","name":"What must be included in a Usability Engineering File?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The Usability Engineering File (UEF) is the core documentation output of the IEC 62366-1 process. It must document the intended use and user groups, use scenarios and user interface specification, formative evaluation records, summative evaluation plan and results, and risk-related findings and how they were addressed. It should be structured to allow a notified body or regulatory reviewer to trace the full usability engineering process from start to finish.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051105497","position":6,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051105497","name":"Does IEC 62366 apply to IVDs?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Yes. IEC 62366-1 applies to all medical devices, including in vitro diagnostic devices (IVDs). Under the EU IVDR and MDR, manufacturers are expected to demonstrate that human factors and usability have been considered as part of the design and development process. This is particularly relevant for IVDs used at the point of care or by lay users, where use errors can have direct patient safety implications.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051121891","position":7,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051121891","name":"How many participants are needed for a summative usability study?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"There is no fixed number mandated by IEC 62366-1, but common practice \u2014 and FDA guidance \u2014 typically expects a minimum of 15 participants per user group for summative evaluations. The number should be justified based on the diversity of the user population, the complexity of the device, and the number of critical tasks being evaluated. For high-risk devices or large user populations, a larger sample may be required.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051138324","position":8,"url":"https:\/\/mdxcro.com\/es\/una-guia-paso-a-paso-de-la-norma-iec-62366-y-la-ingenieria-de-la-usabilidad\/#faq-question-1773051138324","name":"What is the difference between a formative and summative evaluation?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Formative evaluations are iterative assessments carried out during device development to identify and resolve usability problems early. They are exploratory in nature and do not need to meet a pre-defined pass\/fail criterion. Summative evaluations, also called validation testing, are conducted on a near-final or final version of the device to confirm that users can operate it safely and effectively without being coached or corrected. Summative results are what get submitted to regulators.","inLanguage":"es"},"inLanguage":"es"}]}},"_links":{"self":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8428","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/comments?post=8428"}],"version-history":[{"count":24,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8428\/revisions"}],"predecessor-version":[{"id":10746,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8428\/revisions\/10746"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/media\/6348"}],"wp:attachment":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/media?parent=8428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/categories?post=8428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/tags?post=8428"},{"taxonomy":"resources-sector","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/resources-sector?post=8428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}