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INTRODUCTION TO PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES

ONLINE COURSE

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 Introduction to Design Control for Medical Devices online course before this course.

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ONLINE COURSE

Course length10-15 hours
Course fee
(per person)		€ 499
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ONLINE

YOU ARE HERE

€ 499​

Checkmark MDHQ  Average completion time​  10-15 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 32

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ 6 months access to the course and instructor

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ONLINE LIFETIME

€ 599

Checkmark MDHQ  Average completion time​  10-15 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 32

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

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BLENDED

€ 1249 ​

Checkmark MDHQ  Average completion time​  22-27 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 32

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Printed course companion

Checkmark MDHQ  Classroom sessions (2 * 3.5 hours)

Checkmark MDHQ  Templates

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IN-HOUSE TRAINING​

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Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Printed course companion
The personal printed course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.
Templates
Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.
ONLINE
€ 499​
10-15 hours
6.5 hours
32
6 months access
Buy now

You're here

ONLINE LIFETIME
€ 599
10-15 hours
6.5 hours
32
Lifetime access
Buy now
BLENDED
€ 1249
27-22 hours
6.5 hours
32
Lifetime access
Register
IN-HOUSE TRAINING
Contact us
Tailored training to meet your company’s needs
Get a quote

Course description

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).

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.

Sis standard developer 2024 certification
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 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.

Checkmark MDHQ 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.

Checkmark MDHQ 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.

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Course programme

You are required to have good knowledge and experience of design control before starting this course. We also strongly recommend that you take the Introduction to 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 )
  • 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)
  • Optimizing your schedule
  • Using and visualizing 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
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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 10-15 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.

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 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!

If you are planning to attend the live virtual class, you will have to achieve over 85% on the final exam. If you don’t reach 85% on the final exam, we can reset your result for an additional fee.

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.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form. 

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

If you purchase five seats for the same online course at the same time, we will give you one extra seat 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.

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 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.

You are required to have good knowledge and experience of design control before starting this course. We also strongly recommend that you take the Introduction to Design Control for Medical Devices online course before this course.

Testimonials

"Having attended several project management courses, I can for sure say that none of them had the same good blend of high level and details as this. Peter is knowledgeable and his enthusiastic way of presenting, his pragmatic approach to project management combined with real-life examples made the concepts much more tangible and provided me with tools & techniques I can use right away."
Nichlas Holm portrait
Nichlas HolmCertification Engineer, GN Hearing
"This was a very useful course on how to set up and manage a project with a focus on medical device development. It takes you step by step, from initiation and set up through how to manage deviations along the way, and to the close out. Lots of great tips. Strongly recommended."
Magnus Waldt portrait
Magnus WaldtDevice Development Manager, Iconovo AB
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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.

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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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