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.

Introduction to project management for product development of medical devices feature image

ONLINE COURSE

Course length
15-20 hours
Course fee (per person)
€ 499
Purchase the course access for single user:
Purchase the course access for a group of users:

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

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.
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.
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 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
  • Course evaluation
  • Course Evaluation

Do you think you will learn more from a classroom 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. 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 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.
You will have access to the course for six months.
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.

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 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.

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.

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
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.
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.
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.

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.

Still haven’t decided?
Get in touch with us and get more information:

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