Prepare yourself for working in the medical device industry with this introductory, self-paced online course.

Introduction to Working in the Medical Device Industry - Online course feature image
Online course
Course length
3-6 hours
Course fee (per person)
€ 99
Purchase the course access for single user:
Purchase the course access for a group of users:

Course description

This online course focuses on making it easier for you to start working in the medical device industry by providing you with a general understanding of the industry including key concepts and terminology.

It is suitable for anyone planning to, or has just started working with medical devices and wants to gain some insight into the industry and get up to speed faster in their new role.


Topics covered include: an introduction to medical devices, the Quality Management System, how to behave during audits, an introduction to risk management, design control and usability engineering, complaints and vigilance, how to behave in controlled environments including clean rooms, and many other important areas.

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.

Are you a hiring manager?

Make sure your new employees attend this course as part of their onboarding.
Peter Sebelius instructor

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.

Benefits for you

Checkmark MDHQ  Avoid being mute in meetings

The goal is that upon completion of this course, you will not only feel more confident in your ability to understand key medical device concepts and terminology but you will communicate with peers more effectively. You will be able to add value in meetings sooner and avoid doing something that results in undesirable nonconformities.

Checkmark MDHQ  Get information from the source

The instructor is an expert member of the technical committee TC 210 partaking in authoring several key standards for the medical device industry. If you are looking for a course to give you a good grounding in the medical device industry, make sure you choose a course where the instructor has first-hand information.

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

NOTE – The course program structure is subject to change
  • Welcome
  • What you need to know
  • Set your goal completion date
  • Pre-course assessment
  • What is a medical device?
  • Medical device terminology
  • The regulatory background
  • Standards
  • Introduction to audits
  • Quality concepts and audits – Part 1
  • Quality concepts and what to say – Part 2
  • Unannounced audits
  • What is a complaint?
  • The product development process – Part 1
  • The product development process – Part 2
  • Product documentation
  • Introduction to risk management
  • Introduction to usability engineering
  • Keeping things clean and functional
  • Product approval EU
  • Product approval US
  • Post market surveillance
  • Course evaluation

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 3-6 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 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.
The instructor has conducted training in the field of medical devices for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971 and is a trained lead auditor on ISO 13845. 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.


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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