PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES
- Online course
- EU and US requirements
- Intermediate - advanced
- Last updated - March 2026
This online course provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints.
It is a pre-requisite to have good knowledge and experience of design control before starting the course.
We also strongly recommend that you take the Design Control for Medical Devices online course before this course.
Select your course plan
ONLINE
YOU ARE HERE
€ 499 € 299
Average completion time 10-27 hours
Total video duration 6.5 hours
CPD points 19
Number of quizzes 32
Final exam
Course certificate
Downloadable course companion
Ask the instructor
6 months access to the course and instructor
ONLINE LIFETIME
€ 599 € 399 Average completion time 10-27 hours
Total video duration 6.5 hours
CPD points 19
Number of quizzes 32
Final exam
Course certificate
Downloadable course companion
Ask the instructor
Lifetime access to the course and instructor
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
This online course starts where the design control course at Medical Device HQ ends and adds the important layer of project management to the product development process and design control. The course is focused on how to efficiently manage a medical device product development project.
Key topics covered include how to get a project started, defining the scope, budgeting and scheduling to avoid cost and schedule overruns. You will also learn how to monitor and measure the progress of a project.
The course is made up of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate upon successful completion of 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.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
- Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.
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
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.
Understand 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.
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information. This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Course modules
You are required to have good knowledge and experience of design control before starting this course. We also strongly recommend that you take the Design Control for Medical Devices online course before this course.
- Welcome
- What you need to know
- Set your course goal completion dates
- Pre-course assessment
- The medical device world
- The project process – Part 1
- The project process – Part 2
- Medical device project processes
- Projects and project management
- The project organisation
- The project manager and the stakeholders
- The project priorities
- The course outline and tools and techniques
- Develop a project charter
- The project charter paradox
- Project success
- Plan stakeholder engagement
- Planning a project
- Collect requirements – Part 1
- Collect requirements – Part 2
- Define scope – Part 1
- Define scope – Part 2
- Verification and validation planning
- Create WBS
- Baselines
- Introduction to project risk management – Part 1
- Introduction to project risk management – Part 2
- Reserve time and project risk profile – Part 1
- Reserve time and project risk profile – Part 2
- Create a schedule – Part 1
- Create a schedule – Part 2
- Optimising your schedule
- Using and visualising your schedule
- The probability of scheduling
- The critical chain
- Medical device scheduling – Part 1
- Medical device scheduling – Part 2
- Develop the human resource plan
- Project budget and risk – Part 1
- Project budget and risk – Part 2
- Create the project plan
- Direct and manage project work (Design)
- Controling schedule and cost
- Control scope
- Earned value management and forecasting
- Manage communications
- Project close-out
- Pre-final exam
- Final exam
- Course evaluation
- Learn more in a live virtual class
- The live virtual class product
- Get your questions answered on the live virtual class
Frequently asked questions
This online course starts where the design control course at Medical Device HQ ends and adds the important layer of project management to the product development process and design control. The course is focused on how to efficiently manage a medical device product development project.
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.
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.
Key topics covered include how to get a project started, defining the scope, budgeting and scheduling to avoid cost and schedule overruns. You will also learn how to monitor and measure the progress of a project.
You are required to have good knowledge and experience of design control before starting this course. We also strongly recommend that you take the Design Control for Medical Devices online course before this course.
Yes. You can ask the instructor questions in the comment section within the online course. The instructor will endeavour to respond as soon as possible. You will also be able to see participants previous questions and the instructors’ answers.
Our data shows the average time to complete the course is 10-27 hours. Please note, you don’t have to watch the whole course at once. In fact, you can pause, resume and replay the videos as often as you like.
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
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses. A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
Upon completing the course, you will receive a certificate awarding you 19 points (19 CPD hours).
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
You will receive two course certificates upon completion of the online course:
1) A certificate with the final exam score, which is downloadable from your ‘My courses’ page when logged into your account. This is intended for your internal records.
2) A certificate without the final exam score, sent to you by email. This social-medial-friendly certificate is issued on a 3rd party platform and can be added as a certification to your LinkedIn profile should you wish to do so.
The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos, and quizzes to maximize your learning. You cannot download the course; thus you will need to have an internet connection to take the course.
The course is in HTML5 format which will play on any new iOS, Android or Windows devices including mobile phones.
There is no pass/fail score on the final exam. But if you aren’t happy with your result you can pay for an exam reset for 50 EUR.
If you lose internet connection during your final exam please contact support@medicaldevicehq.com. If possible, take a photo or a “print screen” of the screen with your results and e-mail this image to us
We offer several payment methods via our website checkout including credit card, GooglePay, ApplePay, PayPal, depending on the country you are buying from. If you wish to pay by invoice/ bank transfer, or you cannot find your country on the list at checkout, you can submit your order via our invoice order form.
If you purchase five seats for the same online course at the same time, we will give you one extraseat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
NOTE – The course program structure is subject to change.
Reviews
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Group purchase
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.