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€49 for 6 month access
This ‘How to’ course focuses on the practical creation of a medical device design and development 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 design and development plan template with you. This will be automatically added for free to your cart at checkout.
We recommend this course for those that are authoring, reviewing or approving this document and for those that are engaged in creating templates or procedures relating to design and development planning.
The course assumes that you have a good understanding of design control. If you don’t, consider taking the Introduction to Design Control for Medical Devices online course prior to this course.
This 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 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.
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 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.
Once per user