PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES – Practitioner Training
- Blended course: online course + 2 live virtual classroom sessions
- EU and US requirements
- Beginner - advanced
- Last updated - March 2026
It is a pre-requisite to have good knowledge and experience of design control before registering on this course. It is also strongly recommended to take the Design Control for Medical Devices online course since we will build on the knowledge already gained and focus on how to efficiently and effectively manage projects in development of a medical device.
This course provides a high-level overview of the project process as well as hands-on tools and techniques essential to developing a medical device within both budget and schedule constraints. First, you learn the theory via the online course, and after that you apply it during the two live virtual classroom sessions.
2 Live classroom sessions + Templates
€ 1249/ seat
| Course length | approx. 17-34 hours (26 CPD points) |
| Next classroom sessions | TBC 2026 |
Select your course plan
ONLINE
€ 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
BLENDED
YOU ARE HERE
€ 1249
Average completion time 17-34 hours
Total video duration 6.5 hours
CPD points 26
Number of quizzes 32
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Downloadable course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
This course consists of two parts:
1. Project Management for Product Development of Medical Devices online course
2. Two half-day live virtual classroom sessions held by the course creator
It is a pre-requisite to have good knowledge and experience of design control before starting the project management online course. The project management course covers topics such as how to define the scope and requirements of a project and how to create a realistic schedule and budget. You will learn about project risk management and how to avoid cost and schedule overruns.
You can start the online course immediately and have access to it for 6 months, but you must successfully complete the final exam prior to the classroom sessions. If you have already completed the online course, you can register for the classroom sessions only (when available).
The unique, highly interactive live virtual classroom sessions are facilitated by Peter Sebelius, who is an authority in this field. During the sessions, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn first-hand from an industry expert.
A digital course companion is included, as well as time-saving templates on how to implement project management effectively and efficiently.
We recommend this course to 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 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.
Want to know more about our blended courses? Watch the video below.
Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions afterwards.
The online training allows for the flexibility in the way you learn, so that you can learn in a way which 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 would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.
The classroom sessions are highly interactive and focuses on applying the theory you have learnt during the online course 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
Learn how to develop a medical device from beginning to end
This course will guide you through the process from invention or market brief, 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.
Interactive instructor engagement
Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience.
Participate in active learning by asking questions directly to the instructor, taking part in group workshops and discussions. This allows you to seek clarification, share insights, apply and transfer knowledge.
Course structure
Online course
The Project Management for Product Development of Medical Devices online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. You will have lifetime access to the course (conditions apply). The course consists of 16 lessons which are outlined below.
- 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
Classroom session(s)
You will attend these two half-day live virtual instructor-led classroom sessions via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions.
The live virtual classes will cover the practical aspects of the product development process and the most common pitfalls in medical device development, as well as how to avoid them.
The maximum number of people in a classroom session is 8.
Included is a digital course companion and the following time-saving templates:
- Design and development plan template
- Project charter template
- Project close-out report template
- Project deliverables list template
- Stakeholder register template
- Status report template
Frequently asked questions
This course provides a high-level overview of the project process as well as hands-on tools and techniques essential to developing a medical device within both budget and schedule constraints. First, you learn the theory via the online course, and after that you apply it during the two live virtual classroom sessions.
We recommend this course to 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.
You will learn how to develop a medical device from beginning to end. Starting from invention or market brief, pre-studies, to product approval and everything in between, preparing you to lead or take part in that process yourself.
You will also learn about the pitfalls, challenges and issues that many medical device projects face, and not least, how to avoid them.
It is a pre-requisite to have good knowledge and experience of design control before registering on this course. It is also strongly recommended to take the Design Control for Medical Devices online course since we will build on the knowledge already gained and focus on how to efficiently and effectively manage projects in development of a medical device.
Yes. You can ask the instructor questions in the comment section within the online course, and during the classroom sessions.
The instructor will endeavour to respond to any questions left in the online course as soon as possible. You will also be able to see participants previous questions and the instructors’ answers.
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.
The time spent on the course varies greatly. Our data shows the average time to complete the ‘Practitioner Training’ is 17-34 hours. This is based on 10-27 hours to complete the online course and 7 hours of virtual classroom session learning.
Please note, you don’t have to watch the whole online course at once. In fact, you can pause, resume and replay the videos as often as you like.
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 26 CPD points (26 CPD hours).
The blended course consists of two parts: the online course, and two half day live virtual classroom sessions. Several time-saving templates are also provided after the course.
The online course is made up of carefully scripted pre-recorded videos and quizzes, to maximise your learning.
The live virtual classroom sessions are face-to-face sessions where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions.
If you complete the final exam within 6 months of enrolment, you will have lifetime access to the online course (conditions apply). If you do not, your course access will expire after 6 months.
You will receive three course certificates upon completion of the course:
1) An online course certificate with the final exam score, which is downloadable from your ‘My courses’ page when logged into your account.
2) An online course certificate without the final exam score, sent to you by email.
3) A ‘Practitioner Training’ course certificate – covering both the online and live virtual classes – with the final exam score, sent to you by email.
The second and third certificates are both issued on a 3rd party platform and can be added as a certification to your LinkedIn profile should you wish to do so.
It depends. If there are more than 30 days left to the first live virtual class, yes, you can. If there are less than 30 days left to the first live virtual class then, no you cannot without cost.
Please see our cancellation policy here for more information.
Reach out to support@medicaldevicehq.com if you require help.
If you have already completed the online course and taken the final exam more than 3 weeks before the classroom sessions, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the first classroom session. This is because we insist all participants have the information fresh in their mind to maximise the learning experience in the live virtual classroom sessions.
You are required to achieve 85% or more on the final exam to be allowed to attend the classroom sessions. 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.
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 wish to buy 3 or more seats, we invite you to reach out using the Contact Us form to discuss discount options. Please note, if there are 4 or more people from your organisation wising to take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
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