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
    • 1 - How to use this course

  2. 2
    • ISO 14971_Lesson-02

    • ISO 14971_Lesson-02-QUIZ

  3. 3
    • ISO 14971_Lesson-03

    • ISO 14971_Lesson-03-QUIZ

  4. 4
    • ISO 14971_Lesson-04

    • ISO 14971_Lesson-04-QUIZ

  5. 5
    • ISO 14971_Lesson-05a

    • ISO 14971_Lesson-05a-QUIZ

    • ISO 14971_Lesson-05b

    • ISO 14971_Lesson-05b-QUIZ

    • ISO 14971_Lesson-05c

    • ISO 14971_Lesson-05c-QUIZ

  6. 6
    • ISO 14971_Lesson-06

    • ISO 14971_Lesson-06-QUIZ

  7. 7
    • ISO 14971_Lesson-07

    • ISO 14971_Lesson-07-QUIZ

  8. 8
    • ISO 14971_Lesson-08

    • ISO 14971_Lesson-08-QUIZ

  9. 9
    • ISO 14971_Lesson-09

    • ISO 14971_Lesson-09-QUIZ

  10. 10
    • ISO 14971_Lesson-10

    • ISO 14971_Lesson-10-QUIZ

  11. 11
    • Sample Risk Management Plan

    • Sample Risk Management Analysis Report

  12. 12
    • Congratulations

Learning Objectives

Upon completion of this training, students will be able to:

  • 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