Course curriculum

  • 1

    Welcome to the course!

    • 1 - How to use this course

  • 2

    Introduction | PDCA Cycle | Process Approach | Key Terms and definitions

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-02

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-02_QUIZ

  • 3

    Quality Management System | Management Responsibility | Resource Management

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-03

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-03_QUIZ

  • 4

    Product Realization | Measurement, Analysis and Improvement

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-04

    • ISO 13485-2016 Medical Device Systems_Overview_Lesson-04_QUIZ

  • 5

    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

Amazing content | 100% online | Exceptional value

  • 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

Get your CERTIFICATE OF COMPETENCE today!

Additional products

Training On Demand™