{"id":4305,"date":"2022-08-29T13:55:29","date_gmt":"2022-08-29T13:55:29","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&p=4305"},"modified":"2023-10-24T13:07:19","modified_gmt":"2023-10-24T13:07:19","slug":"webinar-on-conformity-assessment-for-medical-devices-samd","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/","title":{"rendered":"Webinar on Conformity Assessment for Medical Devices & SaMD"},"content":{"rendered":"\n

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 the United States Food and Drug Administration (FDA) to organize on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF\u2019s principles of conformity assessment for medical devices as well as a case study for software as a medical device.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n\n\n\n
Portuguese<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

Conformity assessment for medical devices overview and practical implementation<\/h2>\n\n\n\n

Principles of Conformity Assessment for Medical Devices (GHTF\/SG1\/N78:2012<\/a>) – Erin Cutts – USFDA – USA<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Practical Implementation of Conformity Assessment of Medical Devices<\/h2>\n\n\n\n

Practical Implementation of Conformity Assessment of Medical Devices: US FDA – Erin Cutts – USFDA – USA<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Practical Implementation of Conformity Assessment of Medical Devices in Brazil – Francisco Iran Cartaxo – ANVISA – Brazil<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Mukoil Romanos – INVIMA – Colombia<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Practical application of Conformity Assessment of medical devices – Carolina Magnatti – ANMAT – Argentina<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Overview of Conformity Assessment for DMs and Round Table on practical implementation. “Practical implementation of Conformity Assessment for software-oriented DM as DM” – Brenda Guadalupe Olvera – COFEPRIS – Mexico<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Approach to Conformity Assessment for Medical Devices \u2013 The Industry Perspective<\/h2>\n\n\n\n

Approach to Conformity Assessment for Medical Devices \u2013 The Industry Perspective – “Fatemeh Razjouyan – Medtronic<\/p>\n\n\n\n

\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Importance of Harmonization of Conformity Assessment for Medical Devices – Industry Perspective – Duglas Rodr\u00edguez-Calder\u00f3n – Roche Diagnostics<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Conformity assessment for medical devices case study<\/h2>\n\n\n\n

Software as a Medical Device (SaMD) Key Definitions (IMDRF\/SaMD WG\/N12<\/a>) – Cathy Bar – USFDA – USA<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (IMDRF\/SaMD WG\/N12<\/a>) – Brendan O\u2019Leary – USFDA – USA<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Software as a Medical Device (SaMD): Application of Quality Management System (IMDRF\/SaMDWG\/N23<\/a>) – Francisco Iran Cartaxo – ANVISA – Brazil<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Practical Implementation of Conformity Assessment for SaMD<\/h2>\n\n\n\n

MiRa Jacobs – USFDA – USA<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Medical Software Regulation Resolution of the Collegiate Board of Directors – RDC #657 03\/24\/2022 – Francisco Iran Cartaxo – ANVISA – Brazil<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Approach to Conformity Assessment for SaMD \u2013 The Industry Perspective<\/h2>\n\n\n\n

Industry Perspective SaMD Regulatory Challenges – Diane Johnson – Johnson & Johnson MedTech<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Innovative Approaches in SaMD Regulation: Industry Perspective – Duglas Rodr\u00edguez-Calder\u00f3n – Roche Diagnostics<\/h3>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-4305","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nWebinar on Conformity Assessment for Medical Devices & SaMD - 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\/webinar-on-conformity-assessment-for-medical-devices-samd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Webinar on Conformity Assessment for Medical Devices & SaMD - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"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 the United States Food and Drug Administration (FDA) to organize on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF\u2019s principles of conformity assessment…\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/\" \/>\n<meta property=\"og:site_name\" content=\"Regulatory Convergence\" \/>\n<meta property=\"article:modified_time\" content=\"2023-10-24T13:07:19+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/webinar-on-conformity-assessment-for-medical-devices-samd\\\/\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/webinar-on-conformity-assessment-for-medical-devices-samd\\\/\",\"name\":\"Webinar on Conformity Assessment for Medical Devices & SaMD - Regulatory Convergence\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#website\"},\"datePublished\":\"2022-08-29T13:55:29+00:00\",\"dateModified\":\"2023-10-24T13:07:19+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/webinar-on-conformity-assessment-for-medical-devices-samd\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/webinar-on-conformity-assessment-for-medical-devices-samd\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/webinar-on-conformity-assessment-for-medical-devices-samd\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Regulator Sessions\",\"item\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Webinar on Conformity Assessment for Medical Devices & SaMD\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#website\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/\",\"name\":\"Regulatory Convergence\",\"description\":\"Inter-American Coalition\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#organization\",\"name\":\"Inter-American Coalition - Regulatory Convergence\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/wp-content\\\/uploads\\\/sites\\\/4\\\/2021\\\/07\\\/logo_regulatory_retina_en.png\",\"contentUrl\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/wp-content\\\/uploads\\\/sites\\\/4\\\/2021\\\/07\\\/logo_regulatory_retina_en.png\",\"width\":559,\"height\":280,\"caption\":\"Inter-American Coalition - Regulatory Convergence\"},\"image\":{\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/?lang=es\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Webinar on Conformity Assessment for Medical Devices & SaMD - Regulatory Convergence","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/","og_locale":"en_US","og_type":"article","og_title":"Webinar on Conformity Assessment for Medical Devices & SaMD - Regulatory Convergence","og_description":"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 the United States Food and Drug Administration (FDA) to organize on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF\u2019s principles of conformity assessment…","og_url":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/","og_site_name":"Regulatory Convergence","article_modified_time":"2023-10-24T13:07:19+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/","url":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/","name":"Webinar on Conformity Assessment for Medical Devices & SaMD - Regulatory Convergence","isPartOf":{"@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#website"},"datePublished":"2022-08-29T13:55:29+00:00","dateModified":"2023-10-24T13:07:19+00:00","breadcrumb":{"@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-on-conformity-assessment-for-medical-devices-samd\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/"},{"@type":"ListItem","position":2,"name":"Regulator Sessions","item":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/"},{"@type":"ListItem","position":3,"name":"Webinar on Conformity Assessment for Medical Devices & SaMD"}]},{"@type":"WebSite","@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#website","url":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/","name":"Regulatory Convergence","description":"Inter-American Coalition","publisher":{"@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#organization","name":"Inter-American Coalition - Regulatory Convergence","url":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#\/schema\/logo\/image\/","url":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/logo_regulatory_retina_en.png","contentUrl":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/logo_regulatory_retina_en.png","width":559,"height":280,"caption":"Inter-American Coalition - Regulatory Convergence"},"image":{"@id":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?lang=es\/#\/schema\/logo\/image\/"}}]}},"uagb_featured_image_src":[],"uagb_author_info":{"display_name":"Guilherme Guain","author_link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/author\/"},"uagb_comment_info":0,"uagb_excerpt":"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 the United States Food and Drug Administration (FDA) to organize on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF\u2019s principles of conformity assessment…","_links":{"self":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/regulator-sessions\/4305","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/regulator-sessions"}],"about":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/types\/regulator-sessions"}],"wp:attachment":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/media?parent=4305"}],"wp:term":[{"taxonomy":"event_category","embeddable":true,"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/event_category?post=4305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}