ISO 13485-2016 Requirements

This ON DEMAND 16-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Device Quality Management standard and includes a certified training Certificate of Competence. 1.6 CEUs.

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Course curriculum

  1. 1
    • How to use this course

  2. 2
    • ISO 13485-Lesson-02

    • ISO 13485-Lesson-01 and 02-QUIZ

  3. 3
    • ISO 13485-Lesson-03

    • ISO 13485-Lesson-03-QUIZ

  4. 4
    • ISO 13485-Lesson-04a

    • ISO 13485-Lesson-04a-QUIZ

    • ISO 13485-Lesson-04b

    • ISO 13485-Lesson-04b_QUIZ

  5. 5
    • ISO 13485-Lesson-05

    • ISO 13485-Lesson-05-QUIZ

  6. 6
    • ISO 13485-Lesson-06

    • ISO 13485-Lesson-06-QUIZ

  7. 7
    • ISO 13485-Lesson-07a

    • ISO 13485-Lesson-07a-QUIZ

    • ISO 13485-Lesson-07b

    • ISO 13485-Lesson-07b-QUIZ

    • ISO 13485-Lesson-07c

    • ISO 13485-Lesson-07c-QUIZ

    • ISO 13485-Lesson-07d

    • ISO 13485-Lesson-07d-QUIZ

    • ISO 13485-Lesson-07e

    • ISO 13485-Lesson-07e-QUIZ

  8. 8
    • ISO 13485-Lesson-08a

    • ISO 13485-Lesson-08a-QUIZ

    • ISO 13485-Lesson-08b

    • ISO 13485-Lesson-08b-QUIZ

  9. 9
    • Student Handouts

  10. 10
    • Congratulations

Learning Objectives

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

  • Understand medical device quality management definitions, concepts, and guidelines

  • Understand the requirements of the ISO 13485:2016 standard

  • Interpret the clauses of ISO 13485:2016

  • Understand the importance and benefits of an medical device quality management system

  • Understand the process approach

Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

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