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.
Course fee (per person)
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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.
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:
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
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.
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.
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.
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.
NOTE – The course program structure is subject to change
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.
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.
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.
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.