ISO 13485:2016 (Medical Device Quality Management System) Awareness Course

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3 Hours 

Course access time

Course access time is limited to 30 calendar days starting from the day a user has been given access to the learning material. 


$299.00 USD


The attendee will receive our Certificate of Participation after completing the entire course.


This ISO 13485:2016 Awareness Course provides managers and employees with the knowledge required to effectively manage a medical device quality management system.  During this course, you will learn the ISO 13485:2016 Standard requirements and the best practices for a medical device quality management in 7 modules.  As managers/employees in an organization, the more you know about ISO 13485:2016 Standard and the medical device quality management system, the better prepared you are to meet customer and applicable regulatory requirements for your products and services.  

Course Content

Module 1: Background and Introduction of ISO 13485:2016 Standard and Common Terminology 

Module 2: Introduction of ISO 13485:2016 Requirements related to Clause 1 to 3 - Scope, Normative References, Terms and Definitions

Module 3: Introduction of ISO 13485:2016 Requirements related to Clause 4 - Quality Management system

Module 4: Introduction of ISO 13485:2016 Requirements related to Clause 5 - Management responsibility 

Module 5: Introduction of ISO 13485:2016 Requirements related to Clause 6 - Resource Management

Module 6: Introduction of ISO 13485:2016 Requirements related to Clause 7 - Product realization 

Module 7: Introduction of ISO 13485:2016 Requirements related to Clause 8 - Measurement, Analysis & Improvement

Mandatory Documents Required for ISO 13485:2016

Course Summary 

Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016

Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015


Who should attend?

  • Personnel in an organization new to ISO 13485:2016 Standard



Learning Outcomes

Upon completing this course, you will be able to: 

  • Understand the ISO 13485:2016 standard requirements and how to apply the requirements to your company
  • Learn the best practices for medical device quality management 
  • Demonstrate continual improvement of your medical device quality management system