{"id":2592,"date":"2021-08-13T13:24:01","date_gmt":"2021-08-13T13:24:01","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&p=2592"},"modified":"2021-08-13T13:37:55","modified_gmt":"2021-08-13T13:37:55","slug":"usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/","title":{"rendered":"USFDA \u2013 IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP"},"content":{"rendered":"\n

In June, the Medical Device Regulatory Convergence Project<\/a> co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector<\/a> collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series. Sessions from the series focused on ISO 13485 and Medical Device Single Audit Program (MDSAP) outcomes utilization for regulatory purposes, where ANVISA and ANMAT, besides the USFDA share their experiences.<\/p>\n\n\n\n

Presentations and recordings for each session available in English, Portuguese and Spanish:<\/p>\n\n\n\n

Part I, 2 June, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Explain how medical devices inspections are conducted using the MDSAP model based on the ISO 13485, and how agencies may align to ISO 13485.<\/p>\n\n\n\n

Agenda:<\/p>\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

Recording of Session Part I:<\/p>\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

Presentation on MDSAP Audit Model:<\/p>\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

Presentation on Auditing Organization Assessment Program:<\/p>\n\n\n\n

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

Presentation – ANVISA (Good Manufacturing Practices in Brazil: Resolution RDC 16\/2013, similarities and differences compared to ISO 13485:2016):<\/p>\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

Presentation USFDA\u00b4s Transition from CFR820 to ISO 13485:<\/p>\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

Part II, 10 June, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Present how an MDSAP audit is conducted and a case study to explain the audit model based on ISO 13485.<\/p>\n\n\n\n

Agenda:<\/p>\n\n\n\n

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

Recording of Session Part II:<\/p>\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

Presentation on Experience using MDSAP audit model:<\/p>\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

Case Study: Different approaches by the participating regulatory agencies vis a vis an MDSAP audit to highlight the similarities and identify areas of opportunity for alignment:<\/p>\n\n\n\n

\n
Certification Agenda (English)<\/a><\/div>\n\n\n\n
Audit Report (English)<\/a><\/div>\n\n\n\n
Audit Report (Spanish) [Partial Translation]<\/a><\/div>\n\n\n\n
Audit Report (Portuguese) [Partial Translation]<\/a><\/div>\n<\/div>\n\n\n\n

Part III, 17 June, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Explain the MDSAP audit model, present the opportunities to leverage on MDSAP audit outcomes and provide the experience of an Affiliate Member on the process to become one and the benefits obtained.<\/p>\n\n\n\n

Agenda:<\/p>\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

Recording of Session Part III:<\/p>\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:<\/h4>\n\n\n\n

ANVISA\u00b4s use of MDSAP Documents:<\/p>\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

FDA\u00b4s use of MDSAP Documents:<\/p>\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

ANMAT\u00b4s Experience as an Affiliate Member:<\/p>\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

Opportunities to leverage MDSAP outcomes:<\/p>\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","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-2592","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nUSFDA \u2013 IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP - 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\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USFDA \u2013 IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"In June, 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 a webinar series. 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