How to create a Medical Device Risk Management Plan

How to online course

Learn how to create a medical device risk management plan that meets the requirements of ISO 14971:2019, MDR and QSR based on a FREE Medical Device HQ template.

Online course
Course length
1-2 hours
Course fee
(per person)
FREE
Enrol in the course

Course description

This ‘How to’ course focuses on the practical creation of a medical device risk management plan. It answers the questions of: why do you need one, what is it, when do you use it, and how do you create it? In order to get the most out of this course we suggest you have the Medical Device HQ risk management plan template with you. If you don’t have one, you can download it here for FREE.

We recommend this course for those that are authoring, reviewing or approving risk management plans and for those that are engaged in creating templates or procedures relating to risk management planning.

The course assumes that you have a good understanding of risk management. If you don’t, consider taking the Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course.

The online course is made up of pre-recorded videos, quizzes, and a final exam. The final exam consists of 15 questions to be answered in 15 minutes. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course

Peter Sebelius instructor

Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

Course programme

  • Welcome
  • Why and what is it?
  • When to use it?
  • How to create it?
  • Final exam
  • Course evaluation

Would you like to learn more about this topic?

You can register for our Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course here.

Go to the course page

Frequently asked questions

The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.

It takes approximately 1-2 hours to complete the course.

Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.

You will have access to the course for 6 months.
You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
The course is personal, that means you are registering a license for one person.The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase the course through different accounts.
There is no certification or accreditation for risk management, however the instructor has conducted training in the field for many years and continuously participates in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.

It is a pre-requisite to have good understanding of risk management to take this course. If you don’t, you can register for our Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course.

Testimonials

"A very good, practical short course. It brought a new perspective (and template) to a really interesting topic.
Thank you Peter!"
Nadia Caspersen
Nadia CaspersenQuality Assurance Principal Advisor, Qmed Consulting A/S