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