Introduction to Risk Management for Medical Devices and ISO 14971:2019

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249
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Welcome!

Welcome to the course: Introduction to Risk Management for Medical Devices and ISO 14971:2019.

The goals for this course are that you should:

  • Understand the overall process of risk management and how to create safe medical devices
  • Be able to participate in performing risk analysis, risk evaluation and risk control according to ISO 14971:2019
  • Be aware of different risk management tools, such as FMEA and P-FMEA.

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
2024-01-30
How to work
Quiz removed

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