The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry.<\/p>\n
Duration: <\/strong><\/span>9 hours<\/p>\nCEUs: <\/strong><\/span>1.0<\/p>\nModality:<\/strong><\/span> Group<\/p>\nParticipant limit:<\/strong><\/span> 15<\/p>\nDownload Course Technical Information<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\nAt The End Of The Course You Will Be Able To<\/h4>\n\nUnderstand the notion of risk and its relevance in the context of the medical devices industry.<\/li>\nBecome familiar with the legal and regulatory requirements related to risk management in the medical field.<\/li>\nLearn the key terms and definitions related to risk management, establishing a solid knowledge base.<\/li>\nExplore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.<\/li>\nLearn about common tools used to control and mitigate risks associated with products and production processes.<\/li>\nLearn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.<\/li>\nUnderstand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.<\/li>\n<\/ul>\nCourse Content<\/h4>\n\nWhat is Risk and the importance for medical\n\nWelcome to Course, Presentations and Outline Review<\/li>\nReal world RM Case Example<\/li>\nRisk Concept Definition<\/li>\n<\/ul>\n<\/li>\nRegulatory Requirements for Risk Management\n\nISO 13485:2016<\/li>\nMedical Device Directive (MDR)<\/li>\nFDA – 21 CFR 820<\/li>\n<\/ul>\n<\/li>\nKey Terms and Definitions<\/li>\nOverview of ISO 14971:2019<\/li>\nTypical Product and Production Risk Control Tools\n\nRisk Management in Product Design\n\nPreliminary Hazard Analysis<\/li>\nHazards Analysis<\/li>\nUse FMEA<\/li>\nDesign FMEA<\/li>\n<\/ul>\n<\/li>\nRisk Management in Production\n\nProcess FMEA<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nRisk Documents Sustaining and Update\n\nProduction and postproduction activities\n\nProduction Feedback<\/li>\nPost Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)<\/li>\nRisk Documents Sustaining and Update<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nOverall Residual Risk\n\nIndividual and Overall residual risk<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":1741,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1740","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1740"}],"version-history":[{"count":8,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions"}],"predecessor-version":[{"id":2452,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions\/2452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/1741"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1740"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1740"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
CEUs: <\/strong><\/span>1.0<\/p>\nModality:<\/strong><\/span> Group<\/p>\nParticipant limit:<\/strong><\/span> 15<\/p>\nDownload Course Technical Information<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\nAt The End Of The Course You Will Be Able To<\/h4>\n\nUnderstand the notion of risk and its relevance in the context of the medical devices industry.<\/li>\nBecome familiar with the legal and regulatory requirements related to risk management in the medical field.<\/li>\nLearn the key terms and definitions related to risk management, establishing a solid knowledge base.<\/li>\nExplore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.<\/li>\nLearn about common tools used to control and mitigate risks associated with products and production processes.<\/li>\nLearn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.<\/li>\nUnderstand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.<\/li>\n<\/ul>\nCourse Content<\/h4>\n\nWhat is Risk and the importance for medical\n\nWelcome to Course, Presentations and Outline Review<\/li>\nReal world RM Case Example<\/li>\nRisk Concept Definition<\/li>\n<\/ul>\n<\/li>\nRegulatory Requirements for Risk Management\n\nISO 13485:2016<\/li>\nMedical Device Directive (MDR)<\/li>\nFDA – 21 CFR 820<\/li>\n<\/ul>\n<\/li>\nKey Terms and Definitions<\/li>\nOverview of ISO 14971:2019<\/li>\nTypical Product and Production Risk Control Tools\n\nRisk Management in Product Design\n\nPreliminary Hazard Analysis<\/li>\nHazards Analysis<\/li>\nUse FMEA<\/li>\nDesign FMEA<\/li>\n<\/ul>\n<\/li>\nRisk Management in Production\n\nProcess FMEA<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nRisk Documents Sustaining and Update\n\nProduction and postproduction activities\n\nProduction Feedback<\/li>\nPost Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)<\/li>\nRisk Documents Sustaining and Update<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nOverall Residual Risk\n\nIndividual and Overall residual risk<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":1741,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1740","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1740"}],"version-history":[{"count":8,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions"}],"predecessor-version":[{"id":2452,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions\/2452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/1741"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1740"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1740"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Modality:<\/strong><\/span> Group<\/p>\nParticipant limit:<\/strong><\/span> 15<\/p>\nDownload Course Technical Information<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\nAt The End Of The Course You Will Be Able To<\/h4>\n\nUnderstand the notion of risk and its relevance in the context of the medical devices industry.<\/li>\nBecome familiar with the legal and regulatory requirements related to risk management in the medical field.<\/li>\nLearn the key terms and definitions related to risk management, establishing a solid knowledge base.<\/li>\nExplore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.<\/li>\nLearn about common tools used to control and mitigate risks associated with products and production processes.<\/li>\nLearn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.<\/li>\nUnderstand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.<\/li>\n<\/ul>\nCourse Content<\/h4>\n\nWhat is Risk and the importance for medical\n\nWelcome to Course, Presentations and Outline Review<\/li>\nReal world RM Case Example<\/li>\nRisk Concept Definition<\/li>\n<\/ul>\n<\/li>\nRegulatory Requirements for Risk Management\n\nISO 13485:2016<\/li>\nMedical Device Directive (MDR)<\/li>\nFDA – 21 CFR 820<\/li>\n<\/ul>\n<\/li>\nKey Terms and Definitions<\/li>\nOverview of ISO 14971:2019<\/li>\nTypical Product and Production Risk Control Tools\n\nRisk Management in Product Design\n\nPreliminary Hazard Analysis<\/li>\nHazards Analysis<\/li>\nUse FMEA<\/li>\nDesign FMEA<\/li>\n<\/ul>\n<\/li>\nRisk Management in Production\n\nProcess FMEA<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nRisk Documents Sustaining and Update\n\nProduction and postproduction activities\n\nProduction Feedback<\/li>\nPost Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)<\/li>\nRisk Documents Sustaining and Update<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nOverall Residual Risk\n\nIndividual and Overall residual risk<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":1741,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1740","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1740"}],"version-history":[{"count":8,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions"}],"predecessor-version":[{"id":2452,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions\/2452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/1741"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1740"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1740"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Participant limit:<\/strong><\/span> 15<\/p>\nDownload Course Technical Information<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\nAt The End Of The Course You Will Be Able To<\/h4>\n\nUnderstand the notion of risk and its relevance in the context of the medical devices industry.<\/li>\nBecome familiar with the legal and regulatory requirements related to risk management in the medical field.<\/li>\nLearn the key terms and definitions related to risk management, establishing a solid knowledge base.<\/li>\nExplore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.<\/li>\nLearn about common tools used to control and mitigate risks associated with products and production processes.<\/li>\nLearn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.<\/li>\nUnderstand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.<\/li>\n<\/ul>\nCourse Content<\/h4>\n\nWhat is Risk and the importance for medical\n\nWelcome to Course, Presentations and Outline Review<\/li>\nReal world RM Case Example<\/li>\nRisk Concept Definition<\/li>\n<\/ul>\n<\/li>\nRegulatory Requirements for Risk Management\n\nISO 13485:2016<\/li>\nMedical Device Directive (MDR)<\/li>\nFDA – 21 CFR 820<\/li>\n<\/ul>\n<\/li>\nKey Terms and Definitions<\/li>\nOverview of ISO 14971:2019<\/li>\nTypical Product and Production Risk Control Tools\n\nRisk Management in Product Design\n\nPreliminary Hazard Analysis<\/li>\nHazards Analysis<\/li>\nUse FMEA<\/li>\nDesign FMEA<\/li>\n<\/ul>\n<\/li>\nRisk Management in Production\n\nProcess FMEA<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nRisk Documents Sustaining and Update\n\nProduction and postproduction activities\n\nProduction Feedback<\/li>\nPost Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)<\/li>\nRisk Documents Sustaining and Update<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nOverall Residual Risk\n\nIndividual and Overall residual risk<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":1741,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1740","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1740"}],"version-history":[{"count":8,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions"}],"predecessor-version":[{"id":2452,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions\/2452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/1741"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1740"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1740"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Download Course Technical Information<\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\nAt The End Of The Course You Will Be Able To<\/h4>\n\nUnderstand the notion of risk and its relevance in the context of the medical devices industry.<\/li>\nBecome familiar with the legal and regulatory requirements related to risk management in the medical field.<\/li>\nLearn the key terms and definitions related to risk management, establishing a solid knowledge base.<\/li>\nExplore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.<\/li>\nLearn about common tools used to control and mitigate risks associated with products and production processes.<\/li>\nLearn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.<\/li>\nUnderstand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.<\/li>\n<\/ul>\nCourse Content<\/h4>\n\nWhat is Risk and the importance for medical\n\nWelcome to Course, Presentations and Outline Review<\/li>\nReal world RM Case Example<\/li>\nRisk Concept Definition<\/li>\n<\/ul>\n<\/li>\nRegulatory Requirements for Risk Management\n\nISO 13485:2016<\/li>\nMedical Device Directive (MDR)<\/li>\nFDA – 21 CFR 820<\/li>\n<\/ul>\n<\/li>\nKey Terms and Definitions<\/li>\nOverview of ISO 14971:2019<\/li>\nTypical Product and Production Risk Control Tools\n\nRisk Management in Product Design\n\nPreliminary Hazard Analysis<\/li>\nHazards Analysis<\/li>\nUse FMEA<\/li>\nDesign FMEA<\/li>\n<\/ul>\n<\/li>\nRisk Management in Production\n\nProcess FMEA<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nRisk Documents Sustaining and Update\n\nProduction and postproduction activities\n\nProduction Feedback<\/li>\nPost Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)<\/li>\nRisk Documents Sustaining and Update<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\nOverall Residual Risk\n\nIndividual and Overall residual risk<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":1741,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1740","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1740"}],"version-history":[{"count":8,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions"}],"predecessor-version":[{"id":2452,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1740\/revisions\/2452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/1741"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1740"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1740"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in\u00a0real-life risk situations.<\/p>\n