{"id":4306,"date":"2022-08-29T14:04:51","date_gmt":"2022-08-29T14:04:51","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinario-sobre-evaluacion-de-la-conformidad-de-los-dispositivos-medicos-y-software-como-dispositivo-medico\/"},"modified":"2022-09-26T11:54:23","modified_gmt":"2022-09-26T11:54:23","slug":"webinario-sobre-evaluacion-de-la-conformidad-de-los-dispositivos-medicos-y-software-como-dispositivo-medico","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinario-sobre-evaluacion-de-la-conformidad-de-los-dispositivos-medicos-y-software-como-dispositivo-medico\/?lang=es","title":{"rendered":"Webinario sobre Evaluaci\u00f3n de la Conformidad de los Dispositivos M\u00e9dicos y Software como Dispositivo M\u00e9dico"},"content":{"rendered":"\n

El Proyecto de Convergencia Regulatoria de Dispositivos M\u00e9dicos co-liderado por USAID, ANSI, y AdvaMed a trav\u00e9s de la Coalici\u00f3n Interamericana para la Convergencia Regulatoria en el Sector de Tecnolog\u00eda M\u00e9dica, en colaboraci\u00f3n con la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (USFDA) han organizado un webinario el 29 de agosto de 2022, para presentar un panorama general y una implementaci\u00f3n pr\u00e1ctica de los principios de evaluaci\u00f3n de la conformidad de los dispositivos m\u00e9dicos del IMDRF, as\u00ed como un estudio de caso sobre el software como dispositivo m\u00e9dico.<\/p>\n\n

Agenda<\/h2>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Grabaci\u00f3n<\/h2>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n

Panorama de la evaluaci\u00f3n de la conformidad para los dispositivos m\u00e9dicos y mesa redonda sobre la aplicaci\u00f3n pr\u00e1ctica<\/h2>\n\n

Principios de la Evaluaci\u00f3n de la Conformidad para los Dispositivos M\u00e9dicos (GHTF\/SG1\/N78:2012<\/a>) – Erin Cutts, US FDA<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Implementaci\u00f3n Pr\u00e1ctica de la Evaluaci\u00f3n de la Conformidad para Dispositivos M\u00e9dicos<\/h2>\n\n

Erin Cutts, US FDA<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Francisco Iran Cartaxo, ANVISA<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Mukoil Romanos, INVIMA<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Carolina Magnatti, ANMAT<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Brenda Guadalupe Olvera, COFEPRIS<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Enfoque de la Evaluaci\u00f3n de la Conformidad para Dispositivos M\u00e9dicos \u2013 La Perspectiva de la Industria<\/h2>\n\n

Fatemeh Razjouyan, Medtronic<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Duglas Rodr\u00edguez-Calder\u00f3n, Roche Diagnostics<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Caso de estudio de evaluaci\u00f3n de la conformidad para dispositivos m\u00e9dicos<\/h2>\n\n

Software como Dispositivo M\u00e9dico, Definiciones Clave (IMDRF\/SaMDWG\/N12<\/a>) – Cathy Bar, US FDA<\/strong><\/h3>\n\n
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Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Software como Dispositivo M\u00e9dico: Posible Marco de Clasificaci\u00f3n de Riesgos y Consideraciones Pertinentes (IMDRF\/SaMD WG\/N12<\/a>) – Brendan O\u2019Leary, US FDA<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Software como Dispositivo M\u00e9dico: Aplicaci\u00f3n del Sistema de Gesti\u00f3n de Calidad (IMDRF\/SaMDWG\/N23<\/a>) – Francisco Iran Cartaxo, ANVISA<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Implementaci\u00f3n Pr\u00e1ctica de la Evaluaci\u00f3n de la Conformidad para los Dispositivos M\u00e9dicos<\/h2>\n\n

MiRa Jacobs, US FDA<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Francisco Iran Cartaxo, ANVISA<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Enfoque de la Evaluaci\u00f3n de la Conformidad para Software como Dispositivo M\u00e9dico \u2013 La Perspectiva de la Industria<\/h2>\n\n

Diane Johnson, Johnson & Johnson MedTech<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n

Duglas Rodr\u00edguez-Calder\u00f3n, Roche Diagnostics<\/strong><\/h3>\n\n
\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-4306","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nWebinario sobre Evaluaci\u00f3n de la Conformidad de los Dispositivos M\u00e9dicos y Software como Dispositivo M\u00e9dico - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinario-sobre-evaluacion-de-la-conformidad-de-los-dispositivos-medicos-y-software-como-dispositivo-medico\/?lang=es\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Webinario sobre Evaluaci\u00f3n de la Conformidad de los Dispositivos M\u00e9dicos y Software como Dispositivo M\u00e9dico - 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