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 two live virtual classroom sessions.
This course consists of two parts:
1. The Introduction to Project Management for Product Development of Medical Devices online course
2. Two half-day live virtual classroom sessions 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 sessions. If you have already completed the online course, you can register for the classroom sessions only.
The unique, highly interactive live virtual classroom sessions are facilitated by Peter Sebelius, who is an authority in this field. During the sessions, 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 first-hand 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.
Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions 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 sessions are 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.
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.
You will attend these two half-day live virtual instructor-led classroom sessions 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 classes 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:
The blended course consists of two parts: the online course and two half-day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions 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 sessions.
Yes, you can.
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 15-20 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 two half-day live virtual classroom sessions take approximately 7 hours in total.
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.
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 sessions. 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.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, 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 first classroom sessions 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 sessions.
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.
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.
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?