ISO 14971-2019 Risk Management Medical Devices Requirements
This ON DEMAND 6-hour e-course teaches a detailed understanding of the concepts and best practices of the ISO 14971:2019 Medical Device Risk Management standard and includes a certified training Certificate of Competence. 0.6 CEUs.
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Course curriculum
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1
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1 - How to use this course
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2
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ISO 14971_Lesson-02
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ISO 14971_Lesson-02-QUIZ
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3
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ISO 14971_Lesson-03
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ISO 14971_Lesson-03-QUIZ
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4
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ISO 14971_Lesson-04
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ISO 14971_Lesson-04-QUIZ
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5
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ISO 14971_Lesson-05a
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ISO 14971_Lesson-05a-QUIZ
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ISO 14971_Lesson-05b
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ISO 14971_Lesson-05b-QUIZ
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ISO 14971_Lesson-05c
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ISO 14971_Lesson-05c-QUIZ
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6
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ISO 14971_Lesson-06
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ISO 14971_Lesson-06-QUIZ
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7
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ISO 14971_Lesson-07
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ISO 14971_Lesson-07-QUIZ
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8
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ISO 14971_Lesson-08
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ISO 14971_Lesson-08-QUIZ
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9
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ISO 14971_Lesson-09
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ISO 14971_Lesson-09-QUIZ
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10
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ISO 14971_Lesson-10
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ISO 14971_Lesson-10-QUIZ
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11
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Sample Risk Management Plan
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Sample Risk Management Analysis Report
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12
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Congratulations
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Learning Objectives
Upon completion of this training, students will be able to:
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Understand the role of risk management in the medical device industry
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Practice the basics of risk management
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Interpret the clauses and recognize the application of ISO 14971
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Understand the impact of ISO 14971 implementation on medical device organizations
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Recognize the benefits and application of ISO 14971 to ISO 13485
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Certified Risk Manager (CRM) - Medical
The Medical Device - Certified Risk Manager 8-hour training program includes two ON DEMAND e-courses including ISO 14971 Risk Management Medical Devices Requirements and FMEA Failure Mode and Effects Analysis. 0.8 CEUs.
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Guidance for a Culture of Quality
This ON DEMAND 2-hour e-course teaches a brief overview of key concepts for the Guidance for a Culture of Quality and includes a certified training Certificate of Competence. 0.2 CEUs.
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