INTRODUCTION TO PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES
ONLINE COURSEThis is a online 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.
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.
ONLINE COURSE |
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| Course length | 15-20 hours |
| Course fee (per person) |
€ 499
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Purchase the course access for single user:
Course description
This course builds on the knowledge already gained in 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:
- 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
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 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.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the technical committees that are authoring standards such as ISO 13485 and ISO 14971.
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.
Course programme
0. Opening
1. Introduction
- Welcome
- What you need to know
2. The medical device project context
3. Introduction to project management
- Projects and project management
- The project organisation
- The project manager and the stakeholders
- The project priorities
4. Getting the project started
- The course outline and tools and techniques
- Develop a project charter
- The project charter paradox
- Project success
- Plan stakeholder engagement
5. Planning - scope
- 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
6. Planning - project risk management
- 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)
7. Planning - schedule
- 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)
8. Human resources
- Planning – Develop human resource plan
0. Opening
9. The project budget
- Project budget and risk (part 1)
- Project budget and risk (part 2)
10. Create the project plan
- Create the project plan
11. Execution
- Direct and manage project work (Design)
- Controling schedule and cost
- Control scope
- Earned value management and forecasting
- Manage communications
12. Project close out
- Project close out
13. Final exam
- Final exam
14. Course evaluation
- Course evaluation
15. End of course
- End of course
This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.
Frequently asked questions
Is the course a live webinar?
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.
How long does it take to complete the course?
All in all, the average time to complete the course is 15-20 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.
How long will I have access to the course?
You will have access to the course for six months.
What if I lose internet connection during the final exam?
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.
Can I fail the final exam?
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.
Where can I find my course certificate?
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.
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What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on support@medicaldevicehq.com if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer and you will incur an invoicing fee.
Can I view the 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.
Do you offer volume discounts?
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.
Can a colleague and I take the course at the same time?
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.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for design control, 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. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.
What are the pre-requisites for 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.
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.
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:
You will be registered and automatically logged in after the checkout
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
