{"id":57984,"date":"2025-01-03T13:53:06","date_gmt":"2025-01-03T13:53:06","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/formacion-ivdr-reglamento-2017-746-sobre-productos-sanitarios-para-diagnostico-in-vitro\/"},"modified":"2025-01-03T13:53:06","modified_gmt":"2025-01-03T12:53:06","slug":"formacion-ivdr-reglamento-2017-746-sobre-productos-sanitarios-para-diagnostico-in-vitro","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/formacion-ivdr-reglamento-2017-746-sobre-productos-sanitarios-para-diagnostico-in-vitro\/","title":{"rendered":"Formaci\u00f3n IVDR: Reglamento 2017\/746 sobre productos sanitarios para diagn\u00f3stico in vitro"},"content":{"rendered":"<div class=\"flex-shrink-0 flex flex-col relative items-end\">\n<div>\n<div class=\"pt-0\">\n<div class=\"gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full\">\n<div class=\"relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8\">\n<div class=\"flex-shrink-0 flex flex-col relative items-end\">\n<div>\n<div class=\"pt-0\">\n<div class=\"gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full\">\n<div class=\"relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8\">\u00bfEs consciente de c\u00f3mo el <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">nuevo IVDR de la UE<\/a> afectar\u00e1 a su empresa? Afecta a todos los agentes econ\u00f3micos de la cadena de suministro, incluidos fabricantes, distribuidores, importadores y representantes autorizados. <strong>El cumplimiento del IVDR es obligatorio para garantizar el acceso al mercado y mantener la aprobaci\u00f3n regulatoria<\/strong>. Para ayudar a su organizaci\u00f3n a cumplir con los nuevos requisitos del IVDR, GxP Training ofrece un curso certificado online con 9 m\u00f3dulos.  <\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p><b>\u00bfQui\u00e9n debe inscribirse?<\/b><\/p>\n<p>Este curso est\u00e1 dise\u00f1ado para profesionales del sector de <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/productos-sanitarios\/\">productos sanitarios<\/a> para DIV. Es ideal para quienes trabajan en asuntos regulatorios, dise\u00f1o y desarrollo, gesti\u00f3n\/garant\u00eda de calidad, ingenier\u00eda de calidad, auditor\u00eda interna, representantes autorizados y PRRC. <\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><b>Objetivos de aprendizaje: <\/b><\/p>\n<p>Al finalizar este curso, los participantes ser\u00e1n capaces de:<\/p>\n<ul>\n<li>Comprender el marco del IVDR 2017\/746 de la UE<\/li>\n<li>Identificar y clasificar productos sanitarios para DIV<\/li>\n<li>Reconocer las funciones y responsabilidades de los agentes econ\u00f3micos<\/li>\n<li>Explicar los requisitos generales de seguridad y funcionamiento (GSPR)<\/li>\n<li>Comprender los requisitos de cumplimiento continuo (vigilancia poscomercializaci\u00f3n y notificaci\u00f3n de vigilancia)<\/li>\n<li>Describir la documentaci\u00f3n t\u00e9cnica y los requisitos de UDI<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Un curso certificado de GxP Training ofrece una experiencia de aprendizaje altamente interactiva. Cada sesi\u00f3n integra ejemplos reales y cuestionarios. Al finalizar, los participantes recibir\u00e1n un certificado de formaci\u00f3n reconocido mundialmente, acreditado con cr\u00e9ditos CPD\/CEU.  <\/p>\n<p>&nbsp;<\/p>\n<h3><b>Programa:<\/b><\/h3>\n<p><b>Introducci\u00f3n<\/b><\/p>\n<p><b>Lecci\u00f3n 1: Descripci\u00f3n general del Reglamento<\/b><\/p>\n<p><b>Lecci\u00f3n 2: \u00bfQu\u00e9 es un producto sanitario para diagn\u00f3stico in vitro?<\/b><\/p>\n<p><b>Lecci\u00f3n 3: Clasificaci\u00f3n de productos sanitarios para diagn\u00f3stico in vitro<\/b><\/p>\n<p><b>Lecci\u00f3n 4: Agente econ\u00f3mico<\/b><\/p>\n<p><b>Lecci\u00f3n 5: EUDAMED<\/b><\/p>\n<p><b>Lecci\u00f3n 6: UDI y registro<\/b><\/p>\n<p><b>Lecci\u00f3n 7: Evaluaci\u00f3n de la conformidad<\/b><\/p>\n<p><b>Lecci\u00f3n 8: Evidencia cl\u00ednica suficiente<\/b><\/p>\n<p><b>Lecci\u00f3n 9: Vigilancia poscomercializaci\u00f3n<\/b><\/p>\n<p><b>Conclusi\u00f3n<\/b><\/p>\n<p><b>Evaluaci\u00f3n<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00bfEs consciente de c\u00f3mo el nuevo IVDR de la UE afectar\u00e1 a su empresa? Afecta a todos los agentes econ\u00f3micos de la cadena de suministro, incluidos fabricantes, distribuidores, importadores y representantes autorizados. El cumplimiento del IVDR es obligatorio para garantizar el acceso al mercado y mantener la aprobaci\u00f3n regulatoria. Para ayudar a su organizaci\u00f3n a [&hellip;]<\/p>\n","protected":false},"featured_media":48722,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,266],"product_tag":[],"class_list":{"0":"post-57984","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-asuntos-regulatorios","7":"product_cat-productos-sanitarios","9":"first","10":"instock","11":"taxable","12":"shipping-taxable","13":"purchasable","14":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVDR 2017\/746: Formaci\u00f3n certificada sobre el Reglamento de productos sanitarios<\/title>\n<meta name=\"description\" content=\"Curso online certificado IVDR 2017\/746 sobre cumplimiento normativo, UDI, EUDAMED y vigilancia poscomercializaci\u00f3n. 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