INTRODUCTION TO DESIGN CONTROL FOR MEDICAL DEVICES (ONLINE)

ONLINE COURSE

Learn how to be effective in medical device product development during this self paced, interactive online course.

Take a look at our free short course on Design Control:

Online course
Course length
10-12 hours
Course fee (per person)
€ 299
Purchase the course access for single user:
Purchase the course access for a group of users:

Course description

This online course focuses on understanding the process of how to develop new medical devices and maintaining them in organisations where design control requirements apply.

The course mentions both European and US requirements and introduces tools on how to work successfully and efficiently with design control.

We recommend this course for those who are new in the field as well as professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.

The online 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 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 has authored the latest versions of 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.

Benefits for you

Checkmark MDHQ Overview of the process

Knowing where you are in the process is key to making the right next moves. Many of our students come to the course saying that they looked for the perfect overview, and got it.

Checkmark MDHQ Know why and how to work with design control

Design control can be made incredibly abstract if the course content focuses too much on the intangible requirements instead of how to actually do the work. This course is an introduction, it provides an overview of how to find and interpret requirements as well as how to implement them with a lean and pragmatic approach, potentially saving you lots of time.

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 goal completion date
  • Pre-course assessment quiz
  • Why design control and what is it?
  • Agile, waterfall, project management and design control
  • What is a Medical Device?
  • The changing regulatory landscape
  • Speaking design controlish
  • Product documentaton
  • The project process – Part 1
  • The project process – Part 2
  • Why document so much
  • The most essential requirements
  • Why standards?
  • The names and numbers of standards
  • Areas covered by standards
  • Medical device product classification
  • Product approval
  • User needs and design input
  • The V model and requirement traceability
  • How to write requirements
  • How to manage requirements (Part 1)
  • How to manage requirements (Part 2)
  • Introduction to risk management
  • Usability engineering
  • Why planning
  • The design and project plans
  • Other plans and requirements
  • Design review
  • Design and design outputs
  • Process and product requirements
  • What is design transfer?
  • Process validation
  • From design input to end
  • Before you start verification
  • Methods and validation
  • Change control
  • How it all fits together – Part 1
  • How it all fits together – Part 2
  • Course Evaluation

Do you think you will learn more from a classroom course?

This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.

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 10-20 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. 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 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 buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
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 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.
There are no pre-requisites for this course.

Testimonials

Group purchase

You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.

For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.

With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

Still haven’t decided?
Get in touch with us and get more information:

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IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

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