{"id":3975,"date":"2022-05-24T00:41:24","date_gmt":"2022-05-24T00:41:24","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=3975"},"modified":"2022-05-25T14:35:52","modified_gmt":"2022-05-25T14:35:52","slug":"samd","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/imdrf\/imdrf-documents\/samd\/","title":{"rendered":"SaMD"},"content":{"rendered":"\n<h2 class=\"has-accent-color has-text-color wp-block-heading\" style=\"font-size:16px\">Software as a Medical Device (SaMD): Key Definitions<\/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\/1-SaMD-key-definitions-pdf.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\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/02\/imdrf-tech-131209-samd-key-definitions-140901-ESP-Final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"has-accent-color has-text-color wp-block-heading\" style=\"font-size:16px\">&#8220;Software as a Medical Device&#8221;: Possible Framework for Risk Categorization and Corresponding Considerations<\/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\/2-SaMD-Risk-Categorization.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\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/02\/imdrf-tech-140918-samd-framework-risk-categorization-141013_ESP_Final_Version.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"has-accent-color has-text-color wp-block-heading\" style=\"font-size:16px\">Software as a Medical Device (SaMD): Application of Quality Management System<\/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\/3-SaMD-QMS.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\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/02\/imdrf-tech-151002-samd-qms_ESP__Final_Version.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"has-accent-color has-text-color wp-block-heading\" style=\"font-size:16px\">Software as a Medical Device (SaMD): Clinical Evaluation<\/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\/4-SaMD-CLinical-Evaluation.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\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/02\/imdrf-tech-170921-samd-n41-clinical-evaluation_1._ESP_Final_Version.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 .swiper-wrapper, .wpcp-wrapper-118 .wpcpro-row{align-items: center;}#sp-wp-carousel-free-id-118 .wpcp-single-item {box-shadow: 0px 0px 0px 0px #dddddd;transition: all .3s;margin: 0px;}#sp-wp-carousel-free-id-118.swiper-flip .wpcp-single-item{margin: 0!important;}#sp-wp-carousel-free-id-118 .wpcp-single-item:hover {box-shadow: 0px 0px 0px 0px #dddddd;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-single-item {border: 0px solid transparent;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev:hover,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next:hover {background: none;border: 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