Quality Management for Medical Devices and ISO 13485

Current Status

Not Enrolled

Price

299

Get Started

This course is currently closed

Welcome!

Welcome to the course Quality Management for Medical Devices and ISO 13485

The goals for this course are that you should:

  • Understand what quality management is and the benefits of it
  • Work in a medical device company and meet ISO 13485 requirements
  • Analyse if a requirement of the standard has been met or not

Practical information

1) Which internet browser to use

We support Chrome, Edge and Firefox.

Please ensure that your browser is updated to the latest version to avoid technical issues.

2) Mark lessons as complete to continue

We regularly update our online courses, and if any new topics are added, they must be marked as complete before you can continue the course.  

If you have trouble progressing through the course, check if all your previous topics are marked as complete in the course navigation menu on the right-hand side. Completed topics have a green checkmark. 

3) This course is personal

The name and email seen under ”My account” will be displayed on the course certificate. This course is personal and bound to the owner of the account. If you are using someone else’s account, please contact support and we will help you.

4) Trouble?

Don’t hesitate to reach out to us on support@medicaldevicehq.com.

Get your thinking cap on now and get started with the lessons below!

5) Change log

You can find any updates that we make to the course listed here. Please note, corrections of typos and minor changes are not included.

Date Topic Change
2025-07-23
All
Questions and question feedback have been updated
2025-09-05
Classroom session info, case study & more!
New lesson with a video and form added at the end of the course for those why are interested in the classroom session or will be attending
2025-09-16
General
“Introduction to” has been removed from the online course title
2026-04-09
General
Updates throughout the course to align content with the QMSR
Course progress
Course navigation
Course Home

New Quality Management online course update!

We have added a pre-final exam on the Introduction to Quality Management for Medical Devices and ISO 13485 online course so that you can practice once before taking the final exam.

There have also been quiz questions added across all of the course, so if you haven’t finished the course yet and are close to the final exam, it would be beneficial to go through the checkpoint quizzes beforehand. 

If you’re unable to proceed with the course, please go back and complete this quiz.

Course update

We have added a downloadable course companion to this online course which is split into 3 parts throughout the course (start, middle and end). They can be found as separate topics and are called, for example, ‘Download your course companion – Part 1’.

If you are having issues progressing through the course, please go back and click on the course companion topics so they can be marked as complete in the system. Please note, you are not required to download the companion parts for the topics to be marked as complete.

 

Get in touch to receive proposal for customised training

When you submit this form, your personal data will be processed in accordance with our privacy policy.