Course curriculum

  • 1

    Welcome to the course!

    • 1 - How to use this course

  • 2

    Introduction, Key Changes for 2019, Scope

    • ISO 14971_Lesson-02

    • ISO 14971_Lesson-02-QUIZ

  • 3

    Terms and definitions

    • ISO 14971_Lesson-03

    • ISO 14971_Lesson-03-QUIZ

  • 4

    Risk Management Process

    • ISO 14971_Lesson-04

    • ISO 14971_Lesson-04-QUIZ

  • 5

    Risk Analysis Process

    • 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

    Risk Evaluation

    • ISO 14971_Lesson-06

    • ISO 14971_Lesson-06-QUIZ

  • 7

    Risk Control

    • ISO 14971_Lesson-07

    • ISO 14971_Lesson-07-QUIZ

  • 8

    Evaluation of overall residual risk

    • ISO 14971_Lesson-08

    • ISO 14971_Lesson-08-QUIZ

  • 9

    Risk Management Review

    • ISO 14971_Lesson-09

    • ISO 14971_Lesson-09-QUIZ

  • 10

    Production and post-production activities

    • ISO 14971_Lesson-10

    • ISO 14971_Lesson-10-QUIZ

  • 11

    Student Handouts

    • Sample Risk Management Plan

    • Sample Risk Management Analysis Report

  • 12

    Next steps

    • 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

e-Course Benefits

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  • Save time by attending course On Demand, anytime, anywhere, with any device

  • Eliminate travel and lodging expenses

  • Learn through exercises and case study

  • Receive a globally-recognized certificate for successfully completing the course

Who should attend?

  • Quality managers and engineers or implementers within an organization seeking or maintaining registration to ISO 13485

  • Design Engineers, Process Engineers and Manufacturing Engineers

  • Lead auditors and internal auditors

ISO 14971 Risk Management - Medical Devices

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