PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES
BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSIONIt 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 live virtual classroom session(s).
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BLENDED COURSE |
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| Course length | approx. 22-27 hours |
| Next classroom sessions |
21-22 Sep 2021 6-7 Dec 2021 |
| Course fee (per person) | € 1249 |
In case you want to buy the course on someone else’s behalf:
Single seat course purchase is personal and linked to the user account and the email address of the person making the purchase.
If you wish to make the purchase for someone else, they will have to create a separate account, and go through the checkout process. If the participant does not have a suitable credit card, they may select to pay using direct bank transfer as payment method at the end of the checkout process.
Course description
- The Introduction to Project Management for Product Development of Medical Devices online course
- A live virtual classroom session held by the course creator
It is a pre-requisite to have good knowledge and experience of design control before starting the introductory 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 session. If you have already completed the online course, you can register for the classroom session only.
The unique, highly interactive live virtual classroom session is facilitated by Peter Sebelius, who is an authority in this field. During the session, 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 firsthand from an industry expert.
A printed 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.
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 a live virtual classroom session(s) 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 session is 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
Understand why and how to work with project management
Project management can be made incredibly abstract, 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.
Get the big picture
You will get a clear overview of the product development process, as the course covers pitfalls, challenges and issues that many medical device projects face, and last but 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.
Blended learning combines the best of both worlds
You get to learn the theory at your own pace, during the online course, before applying the theory to practice with the guidance of an industry expert. You can get started on the online course right after registration and invoicing.
Course certificate
You will receive a course certificate after the successful completion of the course, which you can show auditors if they ask.
Course structure
Online course
The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. You have the access to the online course for 6 months. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. When you have finished the online course, you will be taking the final exam.
The Introduction to Project Management for Product Development of Medical Devices consists of 23 lessons which are outlined below.
0. Opening
Lesson 1. Introduction
- Welcome
- What you need to know
- Why risk management and what it is? – Part 1
- Why risk management and what it is? – Part 2
Lesson 2. The medical device project context
Lesson 3. Introduction to project management
- Introduction to project management
Lesson 4. Project charter development
- Project charter development
Lesson 5. Identifying stakeholders
- Identifying stakeholders
Lesson 6. Collecting requirements
- Collecting requirements
Lesson 7. Defining scope
- Defining scope
Lesson 8. Creating work breakdown structure
- Creating work breakdown structure
Lesson 9. Creating schedule
- Creating schedule
Lesson 10. Developing a human resource plan
- Develop a human resource plan
Lesson 11. Project risk management
- Project risk management
Lesson 12. Estimating cost and determining budget
- Estimating cost and determining budget
0. Opening
Lesson 13. Develop human resource plan
- Develop human resource plan
Lesson 14. Design review
- Design review
Lesson 15. Direct and manage project execution
- Direct and manage project execution
Lesson 16. Control schedule / Control costs
- Control schedule / Control costs
Lesson 17. Control scope
- Control scope
Lesson 18. Managing communications
- Managing communications
Lesson 19. Monitor and control risk
- Monitor and control risk
Lesson 20. Close project or phase
- Close project or phase
Lesson 21. Final Exam
- Final Exam
Lesson 22. Course Evaluation
- Course evaluation
Lesson 23. Classroom session info, case study & more!
- 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 this 1-day or 2 half-day live virtual instructor-led classroom session(s) 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 class 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 printed course companion and the following time-saving templates:
- Design and development plan
- Project charter template
- Design transfer checklist
- Project close-out report template
- Project deliverables list
- Project risk list
- Requirement traceability matrix
- Stakeholder register
- Status report template
Frequently asked questions
Is the course a live webinar?
The blended course consists of two parts: the online course, and a live virtual classroom session.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom session is a virtual face-to-face 1-day session 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 session.
Can I view the online course on a mobile device?
Yes, you can.
How long does it take to complete the course?
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 8-20 hours to finish on average.
You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like. The live virtual classroom is a 1-day session, or 2 half-days, and lasts approximately for 7 hours.
Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
Do you offer volume discounts?
If you buy more 3 or more seats for one person, we do. Use the contact form to request a quote for 3 or more participants. Please note, if there are more than 5 people from your organisation that should take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
How long will I have access to the course?
You will have access to the online course for six months.
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What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.
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.
What if I have already completed the online course and taken the final exam?
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom session, 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 classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom session.
What are the pre-requisites for this 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 registering on this course.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for design control courses. 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 payment methods do you accept?
The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.
