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

    1. 1 - How to use this course

    1. ISO 14971_Lesson-02

    2. ISO 14971_Lesson-02-QUIZ

    1. ISO 14971_Lesson-03

    2. ISO 14971_Lesson-03-QUIZ

    1. ISO 14971_Lesson-04

    2. ISO 14971_Lesson-04-QUIZ

    1. ISO 14971_Lesson-05a

    2. ISO 14971_Lesson-05a-QUIZ

    3. ISO 14971_Lesson-05b

    4. ISO 14971_Lesson-05b-QUIZ

    5. ISO 14971_Lesson-05c

    6. ISO 14971_Lesson-05c-QUIZ

    1. ISO 14971_Lesson-06

    2. ISO 14971_Lesson-06-QUIZ

  • $295.00

Learning Objectives

After completing this training, students will:

  • Understand the role of risk management in the medical device industry

  • Practice the basics of risk management

  • Interpret the clauses and recognize the application of ISO 14971

  • Understand the impact of ISO 14971 implementation on medical device organizations

  • Recognize the benefits and application of ISO 14971 to ISO 13485

Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

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ISO 14971 Risk Management Medical Devices Requirements