INTRODUCTION TO PROJECT MANAGEMENT FOR PRODUCT DEVELOPMENT OF MEDICAL DEVICES
ONLINE COURSE
This 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
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 as well as risk management and usability engineering.
Information on laws and regulations for 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
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
- Know how to develop a medical device from beginning to end
- Understand the pitfalls of medical device project management and how to avoid them
- Self-paced learning
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
- 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
- Final exam
- Course evaluation
- Final Exam
- Course Evaluation
Do you think you will learn more from a classroom course?
Frequently asked questions
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 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.
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
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.
