{"id":4118,"date":"2022-05-26T02:11:36","date_gmt":"2022-05-26T02:11:36","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&#038;p=4118"},"modified":"2022-06-02T12:09:45","modified_gmt":"2022-06-02T12:09:45","slug":"taller-sobre-certificacion-en-iso-13485","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/taller-sobre-certificacion-en-iso-13485\/?lang=es","title":{"rendered":"Taller sobre Certificaci\u00f3n en ISO 13485"},"content":{"rendered":"\n<p class=\"justified mb-3\">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 Health Canada, ha organizado un Taller sobre Certificaci\u00f3n en la Norma ISO 13485, con el objetivo de conocer la experiencia tanto de un regulador como de un organismo certificador en este proceso.<\/p>\n\n\n\n<h2 class=\"has-accent-color has-text-color has-medium-font-size wp-block-heading\">Agenda<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-3 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/Agenda-ISO-13485-Workshop-COFEPRIS-EN-Final-16May22.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ingl\u00e9s<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/Agenda-ISO-13485-Workshop-COFEPRIS-SP-Final-16May22.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"has-accent-color has-text-color has-medium-font-size wp-block-heading\">Enfoque de Health Canada respecto a la ISO 13485<\/h2>\n\n\n\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-c180157e\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-1982b262\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<h3 class=\"wp-block-heading\" style=\"font-size:18px\"><strong>Grabaci\u00f3n<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.youtube.com\/watch?v=H287hs-3klU\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-7cfd91ec\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<h3 class=\"wp-block-heading\" style=\"font-size:18px\"><strong>Presentaciones<\/strong><\/h3>\n\n\n\n<p><a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/Presentacio%CC%81n-IACRC-2022-05-26-Rev.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Enfoque de Health Canada sobre la ISO 13485 \u2013 Fr\u00e9d\u00e9ric Hamelin<\/a><\/p>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n<h2 class=\"has-accent-color has-text-color has-medium-font-size wp-block-heading\">Enfoque de las Organizaciones Auditoras a la ISO 13485<\/h2>\n\n\n\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-1eb9a351\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-fd6d0364\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<h3 class=\"wp-block-heading\" style=\"font-size:18px\"><strong>Grabaci\u00f3n<\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.youtube.com\/watch?v=2EwkLa1lGlY\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-916661e1\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<h3 class=\"wp-block-heading\" style=\"font-size:18px\"><strong>Presentaciones<\/strong><\/h3>\n\n\n\n<p><a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/202205226-iso-13485-certificacio%CC%81n-Rev.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Enfoque de las organizaciones auditoras a la Norma ISO 13485 \u2013 Eamon Hoxey \u2013 AAMI<\/a><\/p>\n\n\n\n<p><a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/DEKRA-IACRC-Presentacio%CC%81n-26-de-mayo-2022-Rev.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Proceso de Certificaci\u00f3n en ISO 13485, OA \u2013 Billi Jo Johnson \u2013 DEKRA<\/a><\/p>\n<\/div><\/div>\n<\/div><\/section>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-4118","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Taller sobre Certificaci\u00f3n en ISO 13485 - 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\" 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