{"id":4305,"date":"2022-08-29T13:55:29","date_gmt":"2022-08-29T13:55:29","guid":{"rendered":"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&p=4305"},"modified":"2024-01-18T12:15:33","modified_gmt":"2024-01-18T12:15:33","slug":"webinar-on-conformity-assessment-for-medical-devices-samd","status":"publish","type":"policy-training","link":"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/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
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Recording<\/h2>\n\n\n\n
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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
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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
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Practical Implementation of Conformity Assessment of Medical Devices in Brazil – Francisco Iran Cartaxo – ANVISA – Brazil<\/h3>\n\n\n\n
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Mukoil Romanos – INVIMA – Colombia<\/h3>\n\n\n\n
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Practical application of Conformity Assessment of medical devices – Carolina Magnatti – ANMAT – Argentina<\/h3>\n\n\n\n
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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
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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

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Importance of Harmonization of Conformity Assessment for Medical Devices – Industry Perspective – Duglas Rodr\u00edguez-Calder\u00f3n – Roche Diagnostics<\/h3>\n\n\n\n
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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
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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
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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
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Practical Implementation of Conformity Assessment for SaMD<\/h2>\n\n\n\n

MiRa Jacobs – USFDA – USA<\/h3>\n\n\n\n
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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
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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
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Innovative Approaches in SaMD Regulation: Industry Perspective – Duglas Rodr\u00edguez-Calder\u00f3n – Roche Diagnostics<\/h3>\n\n\n\n
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Spanish<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"menu_order":0,"template":"","event_category":[],"class_list":["post-4305","policy-training","type-policy-training","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:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/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:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/webinar-on-conformity-assessment-for-medical-devices-samd\/\" \/>\n<meta property=\"og:site_name\" content=\"Regulatory Convergence\" \/>\n<meta property=\"article:modified_time\" content=\"2024-01-18T12:15:33+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:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/webinar-on-conformity-assessment-for-medical-devices-samd\/\",\"url\":\"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/webinar-on-conformity-assessment-for-medical-devices-samd\/\",\"name\":\"Webinar on Conformity Assessment for Medical Devices & SaMD - 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