{"id":4099,"date":"2022-05-26T02:05:18","date_gmt":"2022-05-26T02:05:18","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&#038;p=4099"},"modified":"2023-10-24T13:12:51","modified_gmt":"2023-10-24T13:12:51","slug":"workshop-on-iso-13485-certification","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/workshop-on-iso-13485-certification\/","title":{"rendered":"Workshop on ISO 13485 Certification"},"content":{"rendered":"\n<p class=\"justified mb-3\">The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with Health Canada to organize a workshop on Certification on ISO 13485 with the objective to learn on the experience from a regulator and an auditing organization on this process.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-accent-color has-text-color has-medium-font-size\">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 wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/Agenda-ISO-13485-Workshop-COFEPRIS-EN-Final-16May22.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/Agenda-ISO-13485-Workshop-COFEPRIS-SP-Final-16May22.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-dark-gray-color has-text-color has-medium-font-size\"><strong>Health Canada Approach to ISO 13485<\/strong><\/h2>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Recording<\/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.youtube.com\/watch?v=2EWtU_qFxoQ\" 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\">Health Canada Approach to ISO 13485 &#8211; Fr\u00e9d\u00e9ric Hamelin &#8211; Health Canada &#8211; Canada<\/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=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/IACRC-Presentation-2022-05-26.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-dark-gray-color has-text-color has-medium-font-size\"><strong>Auditing Approach to ISO 13485<\/strong><\/h2>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Recording<\/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.youtube.com\/watch?v=HqNF8W7By5I\" 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\">Approach of Auditing Organizations to ISO 13485 &#8211; Eamonn Hoxey &#8211; AAMI &#8211; USA<\/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=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/202205226-iso-13485-certification.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\">ISO 13485 Certification Process &#8211; Billi Jo Johnson &#8211; Dekra<\/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=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/05\/DEKRA-IACRC-Presentation-26-May-2022-Repaired.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-4099","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>Workshop on ISO 13485 Certification - 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\/workshop-on-iso-13485-certification\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" 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