Course curriculum

  • 1

    Welcome and how to use this e-course

    • How to use this course

  • 2

    Overview, Clarification of Concepts, and The Process Approach

    • ISO 13485-Lesson-02

    • ISO 13485-Lesson-01 and 02-QUIZ

  • 3

    Key Terms and definitions

    • ISO 13485-Lesson-03

    • ISO 13485-Lesson-03-QUIZ

  • 4

    Quality Management System

    • ISO 13485-Lesson-04a

    • ISO 13485-Lesson-04a-QUIZ

    • ISO 13485-Lesson-04b

    • ISO 13485-Lesson-04b_QUIZ

  • 5

    Management Responsibility

    • ISO 13485-Lesson-05

    • ISO 13485-Lesson-05-QUIZ

  • 6

    Resource Management

    • ISO 13485-Lesson-06

    • ISO 13485-Lesson-06-QUIZ

  • 7

    Product Realization

    • 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

    Measurement, Analysis and Improvement

    • ISO 13485-Lesson-08a

    • ISO 13485-Lesson-08a-QUIZ

    • ISO 13485-Lesson-08b

    • ISO 13485-Lesson-08b-QUIZ

  • 9

    Student Handouts

    • Student Handouts

  • 10

    Next Steps

    • 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

ISO 13485 Requirements

Get your CERTIFICATE OF COMPETENCE today!

Additional products

Training On Demand™