How to create a Medical Device Design and Development Plan

How to online course

Learn how to create a medical device design and development plan based on a Medical Device HQ template and address the requirements in 7.3.2 in ISO 13485 and 820.30 in QSR.

Online course
Course length
1-2 hours
Course fee
(per person)
FREE 10 day access
(limited time offer)
€49 for 6 month access
Access the course for single user:

Course description

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 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 Design Control for Medical Devices online course here.

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.

It depends. You can gain access for free for 10 days or pay 49 EUR for 6 months access.

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.
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. If you have more than one person needing the course, please register them on the course through a different account.
There is no certification or accreditation for design control, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.

It is a pre-requisite to have good understanding of design control to take this course. You can register for our ‘Introduction to Design Control for Medical Devices’ online course here, if necessary.

Testimonials

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