{"id":4881,"date":"2024-04-02T21:02:04","date_gmt":"2024-04-02T21:02:04","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=policy-training&#038;p=4881"},"modified":"2025-02-06T12:11:43","modified_gmt":"2025-02-06T12:11:43","slug":"inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-session","status":"publish","type":"policy-training","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-session\/","title":{"rendered":"Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector \u2013 External Stakeholders Session\u00a0\u2013 March 14, 2024"},"content":{"rendered":"\n<p>The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector hosted the &#8220;External Stakeholders Hybrid Meeting&#8221; in Washington D.C. on March 14. Topics covered during the event included The Role of Manufacturers in Ensuring Quality, Safety &amp; Performance, Initiatives to Increase the Use of International Standards for Medical Devices, Key Initiatives in the Medical Device Sector, GRP &amp; TBT; MDR \/ IVDR; GMDN and Measures to Align El Salvador&#8217;s Medical Device Regulatory Framework with International References.<\/p>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Agenda<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/Agenda.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Presentations<\/h2>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>The Role of Manufacturers in Ensuring Quality, Safety &amp; Performance &#8211; Regulatory Authority Views &#8211; Scott Colburn &#8211; USFDA<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/1-Scott-Colburn-FDA.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>The Role of Manufacturers in Ensuring Quality, Safety &amp; Performance &#8211; Regulatory Authority Views &#8211; Thiago Cunha &#8211; ANVISA<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/2-Thiago-Rezende-Anvisa.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>The Role of Manufacturers in Ensuring Quality, Safety &amp; Performance &#8211; Manufacturer\u2019s Views &#8211; Fatemeh Razjouyan, Medtronic and Tammy Steuerwald, Roche Diagnostics<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/3-Fatemeh-Tammy.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Medical Device International Standardization &#8211; Initiatives to increase use of international standards for medical devices and engagement in Standards Development Organizations for medtech across the Americas &#8211; Terry Woods &#8211; USFDA<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/4-Terry-Woods-slides.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Direcci\u00f3n Nacional de Medicamentos, El Salvador &#8211; Karina Flores &#8211; DNM Mario Vega &#8211; DNM<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/5-DNM.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>GMDN Overview &#8211; Deniz Bruce \u2013 GMDN<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/04\/6-Deniz-GMDN-.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"menu_order":0,"template":"","event_category":[],"class_list":["post-4881","policy-training","type-policy-training","status-publish","hentry","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector \u2013 External Stakeholders Session\u00a0\u2013 March 14, 2024 - 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\/policy-training\/inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-session\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector \u2013 External Stakeholders Session\u00a0\u2013 March 14, 2024 - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector hosted the &#8220;External Stakeholders Hybrid Meeting&#8221; 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