11-49-21-1001

Risk Management as per ISO 14971:2019

E-Learning60 MinutesBeginnerSelf-paced / e-Learning

This e-Learning self-paced course will introduce you to the ISO standard of 14971:2019. It will help you answer some important questions like: What impact do the new revisions of the standards ISO 14971:2019 and ISO/TR 24971:2020 have on risk management? How does the standard relate to MDR? If you take a closer look of the standard, there are numerous details and possibilities to improve important contents in risk management sustainably.

This course is specially designed for Product and process developers, medical device manufacturers and their suppliers, employees in quality management and regulatory affairs, QM representatives, safety representatives for medical devices, as well as consultants and service providers.

Upon successful completion of this E-learning module, you will have a clear understanding of the following:

  • New terms and definitions
  • Changed structure and contents
  • Overview of the changes in ISO 14971:2019 and ISO/TR 24971:2020
  • Consideration of the requirements of (EU) 2017/745 MDR
  • Overview ISO/TR 24971:2020

In this e-Learning course you will get to know the innovation of ISO 14971:2019 as well as an overview of ISO/TR 24971:2020. You will understand how to implement the changes of the new ISO 14971:2019 in your company. The connections between MDR and risk management will be explained to you. At the end of the e-Learning you can test your knowledge in a short knowledge test.

  • You get to know the essential changes of ISO 14971:2019.
  • You can estimate what the ISO 14971:2019 means for your own company.
  • The e-Learning is available worldwide, 24 hours a day, 7 days a week.
  • You decide for yourself what you would like to learn, when, how often, and for how long.

The cumulative duration of the programme is 60 min., after which you will be required to pass a quiz to receive your internationally recognised e-certificate with a unique ID.

System requirements

Supported browsers include:

  • Chrome
  • Safari
  • Internet Explorer
  • Firefox

Additional requirements include:

  • A high speed internet connection will provide best results.
  • An email address is required to register for courses.
  • Microsoft Media Player or equivalent is needed to play audio and video files.
  • Flash Player is used for content and interactive learning. If necessary download and install Flash Player to ensure proper operation of course content.

What is included with the course?

Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

Can I pause the course and log in to it anytime?

Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

Are there any quizzes in the middle of the course?

Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

Can I get a refund if I cancel my enrollment?

Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

What happens if I don’t finish the course within the access period?

The standard access period is 365 days to allow sufficient time to complete your course.

If you have questions, or require assistance, you may reach us at [email protected]

To learn more about TÜV SÜD, please click here.


If you are unable to purchase online please contact our team today at [email protected] or (978) 573-1997.

Price (excl. TAX)
$ 110.00

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