This is a blended (online + live virtual classroom session) course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. A pre-requisite for this course is that you have taken the Introduction to Design Control for Medical Devices online course.


Course length approx.
18-24 hours
Next classroom sessions
10-11 May 2021
Course fee (per person) € 1099

Course description

This course builds on the knowledge already gained on the Design Control for Medical Devices course and focuses on how to efficiently and effectively project manage the development of a medical device.

Key topics covered include:

  • the level of documentation that is required
  • how to define requirements
  • the requirements that must be met to CE mark a product
  • how to budget and schedule to avoid cost and schedule overruns
  • risk management and usability engineering.

Information on laws and regulations from CE marking, risk management (ISO 14971), usability (EN 62366) and other standards are referenced within the course.

We recommend this course for:

R&D engineers wanting to become project managers, consultants working with medical device projects, project managers within the medical device industry, and managers working directly or indirectly with projects and product development


What is a blended course?

Our blended learning courses combine the best of two worlds: online training with live virtual classroom sessions. You get to learn the theory first at your own pace, during the online course, before applying theory in practice with the guidance of the expert instructor. 

The online training provides flexibility in how you learn so you can learn in a way that suits you best. You can access it whenever and wherever you want and you can stop, start and repeat the lessons and quizzes as often as you like. To help maximise your learning we assess your knowledge and understanding at the start and throughout the online training, culminating with a final exam at the end. 

The classroom session is highly interactive and focuses on applying the theory in practice with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions!  

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.

Benefits for you

Start right away

You can get started on the online course after registration and invoicing.

Know how to develop a medical device from beginning to end

This course will guide you through the process from invention or market brief, through pre-studies, to product approval and everything in between, preparing you to lead or take part in that process yourself.

How to avoid missing project deadlines

A challenging part for many is how to ensure a project finishes on time. The course has a comprehensive lesson on scheduling and how to avoid schedule slippage, cost and embarrassment of not delivering on time.

Know the pitfalls of medical device project management and how to avoid them

We don’t live in a perfect world. This course talks about pitfalls, challenges and issues that many medical device projects face, and not least, how to avoid them. This will prepare you and make you ready to combat a lot of difficult situations in your work-life.

95% says it is the best course they have ever taken

This course is spot on for project managers and consultants wanting to excel in the medical device industry. It is not a sit-back-and-relax course, the pace is fast and the course is demanding. Even so, 95% of participants report that it is the best course they have taken.

Course programme

You are required to have taken the Introduction to Design Control for Medical Devices online course in order to apply for this course.

This blended course is done in two parts: an online course with a final exam and a classroom session.

Online course structure

NOTE – Course programme is subject to change

0. Opening
1. Introduction
  • Welcome
  • What you need to know
  • Why risk management and what it is? – Part 1
  • Why risk management and what it is? – Part 2
2. Introduction to project management
  • Introduction to project management
3. Project charter development
  • Project charter development
4. Identifying stakeholders
  • Identifying stakeholders
5. Collecting requirements
  • Collecting requirements
6. Defining scope
  • Defining scope
7. Creating work breakdown structure
  • Creating work breakdown structure
8. Creating schedule
  • Creating schedule
9. Developing a human resource plan
  • Develop a human resource plan
10. Project risk management
  • Project risk management
11. Estimating cost and determining budget
  • Estimating cost and determining budget
0. Opening
12. Develop human resource plan
  • Develop human resource plan
13. Design review
  • Design review
14. Direct and manage project execution
  • Direct and manage project execution
15. Control schedule / Control costs
  • Control schedule / Control costs
16. Control scope
  • Control scope
17. Managing communications
  • Managing communications
18. Monitor and control risk
  • Monitor and control risk
19. Close project or phase
  • Close project or phase
20. Pre-classroom survey
  • Pre-classroom survey
21. Final Exam
  • Final Exam
22. Course Evaluation
  • Course evaluation

Classroom session

1-day or 2-half days live virtual instructor-led classroom session working on case studies & real-life scenarios

Frequently asked questions

Is the course a live webinar?

The blended course comprises two parts: the online course and a live virtual classroom session.

The online course is made up of carefully scripted pre-recorded videos to maximize your learning. The live virtual classroom session is a virtual face-to-face 1-day session where you will be interacting with the instructor and course participants via Zoom. You are required to be visible on video when taking the classroom session.

Can I view the online course on a mobile device?

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

How long does it take to complete the course?

All in all, the average time to complete the blended course is 18-24 hours. The online course takes approximately 10-16 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 live virtual classroom is a 1-day or 2-half day sessions and lasts approximately 8 hours.

Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to My Courses, and scroll down. You will find it under Your course certificates.

After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.

Do you offer volume discounts?
If you buy more 3 or more seats, we do. Use the contact form to request a quote for 3 or more participants.
How long will I have access to the course?
You will have access to the online course for six months.
What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
No, you cannot fail the final exam. However, it is required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good marker on what you will get on the final exam.

If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR and you can take it again.

What are the pre-requisites for this course?
Recommended minimum pre-requisites for this course are any or all of the following: experience with product development in a regulated industry, experience from working in project organisation, or with ISO 13485/21 CFR 820.
Is the instructor accredited or certified to provide training?
For the design control elements of the course, there is no certification or accreditation, 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. Ensuring the instructor has the most up to date knowledge and information is the highest qualifications for teaching the course.
What payment methods will you accept?
After signing up on the course registration page, we will send you the invoice for the course.


Although this was a virtual online course it was a great learning experience. The presenter had a lot of experience and was very motivating and inspiring. The course gave a perfect overview, there was plenty of time to practice, and the interactive format worked very well. My learnings from the course probably are just as good as if it would have been a classroom course.
Kristen Thomsen

Consultant, KriT Consult

This course was great! The instructors energy and enthusiasm came across just as if we were in a traditional classroom setting. I thought the online part of the course was engaging and interactive and the checkpoint quizzes were really useful.
Mikael Arinder

Vice President Operations, Iconovo AB

Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course