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.
A pre-requisite for this course is that you have taken the Introduction to Design Control for Medical Devices online course.
ONLINE COURSE |
|
|---|---|
| Course length | 10-16 hours |
| Course fee (per person) |
€ 449
|
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:
- 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
Do you want to order this course
for multiple people?
If you want to buy this course for more than one person at a time, please enquire about our group purchase option by clicking on this button. It will take you to a form to fill in and someone will aim to be in touch with you within 24 hours (Mon- Fri) to discuss your requirements.
If you want to order more than 5 seats, we can offer you a discounted price!
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.
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.
Course programme
You are required to have taken the Introduction to Design Control for Medical Devices online course in order to register to this course.
0. Opening
1. Introduction
- Welcome
- What you need to know
2. Introduction to project management
- Projects and project management
- The project organisation
- The project manager and the stakeholders
- The project priorities
3. Getting the project started
- The course outline and tools and techniques
- Develop a project charter
- The project charter paradox
- Project success
- Plan stakeholder engagement
4. 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
5. 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)
6. 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)
7. Human resources
- Planning – Develop human resource plan
0. Opening
8. The project budget
- Project budget and risk (part 1)
- Project budget and risk (part 2)
9. Create the project plan
- Create the project plan
10. Execution
- Direct and manage project work (Design)
- Controling schedule and cost
- Control scope
- Earned value management and forecasting
- Manage communications
11. Project close out
- Project close out
12. Final exam
- Final exam
13. Course evaluation
- Course evaluation
14. 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
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, for 6 months. 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 10-16 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 only limitation is the final exam, where you will only have one shot.
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.
What payment methods will you accept?
The preferred method of payment is by credit card. But you can also select to be invoiced and pay using wire transfer. 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 or Android.
Do you offer volume discounts?
If you buy 5 seats or more, you can be offered a volume discount. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing and we will get back to you.
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.
Where can I find my course certificate?
What are the pre-requisites for this course?
You are required to have taken the Introduction to Design Control for Medical Devices online course in order to register to 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 buy our online courses one seat at a time through the shopping cart on Medical Device HQ using a credit card or bank transfer.
If you would like to buy multiple seats, please complete this form and someone will aim to get back to you within 24 hours (Mon-Fri) to discuss your requirements.
If you want to order more than 5 seats, we can offer you a discounted price!
With a group purchase, you will receive group leader access which will enable you to manage your own group including adding & removing participants and receiving progress reports & quiz reports.
Alternatively you can simply purchase the number of seats you require by clicking on this button that will take you to the product page.