{"id":2283,"date":"2021-07-08T17:33:10","date_gmt":"2021-07-08T17:33:10","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=2283"},"modified":"2021-07-08T17:47:38","modified_gmt":"2021-07-08T17:47:38","slug":"imdrf-essential-principles","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/imdrf\/imdrf-essential-principles\/","title":{"rendered":"IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"205\" height=\"275\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/IMDRF-Essential-Principles-Picture.png\" alt=\"\" class=\"wp-image-2285\"\/><\/figure>\n\n\n\n<p>This document lists essential principles with internationally recognized technical standards that can be used during the design and manufacturing process to demonstrate compliance of medical devices with safety and performance requirements.<\/p>\n\n\n\n<p class=\"mb-3\">To read the document , click&nbsp;<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-181031-grrp-essential-principles-n47.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a>.<\/p>\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: 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#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: none;font-size: 30px;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev i,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next i {color: #aaa;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev i:hover,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next i:hover {color: #52b3d9;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-swiper-dots .swiper-pagination-bullet {background-color: #cccccc;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-swiper-dots .swiper-pagination-bullet.swiper-pagination-bullet-active {background-color: #52b3d9;} 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width=\"240\" height=\"64\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_aldimed.jpg\" alt=\"member_aldimed\" width=\"240\" height=\"39\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_amid.jpg\" alt=\"member_amid\" width=\"240\" height=\"98\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_advamed.jpg\" alt=\"member_advamed\" width=\"240\" height=\"65\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"wpcp-swiper-dots swiper-pagination\"><\/div>\n\t\t\t\t<!-- If we need navigation buttons -->\n\t\t\t\t\t<div class=\"wpcp-prev-button swiper-button-prev\"><i class=\"fa fa-angle-left\"><\/i><\/div>\n\t\t\t<div class=\"wpcp-next-button swiper-button-next\"><i class=\"fa fa-angle-right\"><\/i><\/div>\n\t\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>This document lists essential principles with internationally recognized technical standards that can be used during the design and manufacturing process to demonstrate compliance of medical devices with safety and performance requirements. To read the document , click&nbsp;here.<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":577,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-2283","page","type-page","status-publish","hentry","description-off"],"acf":[],"featured_image_src":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - 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\/policy\/medical-device-sector-regulatory-convergence\/imdrf\/imdrf-essential-principles\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"This document lists essential principles with internationally recognized technical standards that can be used during the design and manufacturing process to demonstrate compliance of medical devices with safety and performance requirements. 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