ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019

ONLINE COURSE - COMING SOON

COMING SOON

Become an expert in risk management for medical devices during this specialist, state-of-the-art, interactive online course.

It is a pre-requisite to have good knowledge and experience of risk management before starting the course.

We strongly recommend that you take the Introduction to Risk Management for Medical Devices online course before this course.

Advanced Risk Management for Medical Devices and ISO 14971:2019 online course feature image
Online course
Course length
10-15 hours
Course fee (per person)
€ 449

Would you like to get this course for FREE?

We are currently looking for people to validate this course in exchange for free course enrolment.

Please apply to be a validator by clicking on the button which will take you to an application form.

Course description

This online course will provide you with a much deeper understanding of the concepts covered in the introductory risk management course.

It will deliver more information on the risk management process and procedure, and risk management planning. 

It will also provide an in-depth review of the different concepts of risk, what risks to include in the risk assessment, the risk control process, and how the required traceability can be achieved.

The course is aimed at people who are:

  • Leading risk management work;
  • Editing, reviewing and approving risk management procedures and templates;
  • Involved in risk management remediation efforts;
  • Auditors of risk management and QA professionals.

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

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Peter Sebelius instructor

Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience too having developed, amongst other things, a mechanical chest compression 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.

Benefits for you

Checkmark MDHQ Become the expert

The goal is that upon completion of this course you should be able to evaluate the effectiveness of risk management processes, analyse conformity to regulatory requirements of risk management and recommend different approaches to risk management for different situations.

Checkmark MDHQ Get information from the source

The instructor is a member of JWG3 that authors the ISO 14971 standard. This means you will be getting first hand information. And at the end of the course you will receive a certificate that proves to regulatory bodies that you are competent in risk management.

Checkmark MDHQ Self-paced learning

You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.

Course programme

  • Welcome
  • What you need to know
  • Set your course completion date
  • Pre-course assessment
  • Creating a common ground
  • The system, process and procedure
  • The documentation structure – Part 1
  • The documentation structure – Part 2
  • The different concepts of risk – Part 1
  • The different concepts of risk – Part 2
  • Risk management planning – Part 1
  • Risk management planning – Part 2
  • Risk management planning – Part 3
  • The risk analysis process – Part 1
  • The risk analysis process – Part 2
  • The risk analysis process – Part 3
  • What to include in the risk analysis – Part 1
  • What to include in the risk analysis – Part 2
  • What to include in the risk analysis – Part 3
  • The design, process and use – Part 1
  • The design, process and use – Part 2
  • Challenges with Po
  • The most common mistake in RM and the solution – Part 1
  • The most common mistake in RM and the solution – Part 2
  • The most common mistake in RM and the solution – Part 3
  • The risk control process
  • Inherent safety by design and protective measures
  • Information for safety and disclosure of residual risk – Part 1
  • Information for safety and disclosure of residual risk – Part 2
  • Verification of effectiveness of risk controls
  • The alternative HTM and risk control
  • Risk management as a database
  • How to document risk assessment and risk control – Part 1
  • How to document risk assessment and risk control – Part 2
  • Should you have a software tool for risk management?
  • Course evaluation

NOTE – The course program structure is subject to change

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.

All in all, the average time to complete the course is 10-15 hours. 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 attempt at taking it.

You will have access to the course for six 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.

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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 another seat on the course.
There is no certification or accreditation for risk management, however the instructor has conducted training in the field for many years and continuously participate in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.

You are required to have good knowledge and experience of risk management before starting this course. We also strongly recommend that you take the Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course before this course.

Would you like to be a validator for this course?

  • We're currently looking for validators for the upcoming Advanced Risk Management for Medical Devices online course. Please fill in the form and we will get back to you.
  • When you submit this form, you will be sending personal information to medicaldevicehq.com. To comply with GDPR requirements, we need your consent to store and use the personal data you submit. Your personal data will be used in our customer relationship management system and our ticket system. We will not send you unsolicited emails.
  • Please press the REGISTER button. If you have any questions, don't hesitate to contact us!

    Peter Sebelius
    Founder, Medical Device HQ