This 4-day course provides a high level overview for developing a medical device as well as the tools and techniques for project delivery.

Promotional video for the course project management for product development of medical devices


Course length
4 days
Course fee (per person)
€ 2490
90-day early bird special
€ 2240

Course description

The course has an integrated approach to project management and is suitable for a range of different job roles within the medical device sector. Topics include how to define requirements, which requirements must be met to CE mark a product, and where risk analysis and usability should be introduced into a product development project.

Information on laws and regulations from CE marking, risk management (ISO 14971), usability (EN 62366) and other standards are referenced within the course.

All the subject matter of the Design Control course is also included within this course.

Due to the current COVID-19 situation, we are continuously evaluating when and how we can safely run classroom courses. If you are interested in attending a classroom course, please register you interest by filling out the form below.

Alternatively, we offer this course as an online + live virtual classroom course.

Notify me when the next classroom course becomes available

Peter Sebelius instructor

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.
A challenging part for many is how to ensure a project finishes on time. The course has a comprehensive lesson on scheduling and how to avoid schedule slippage and the embarrassment of not delivering on time.
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.
This course is spot on for project managers and consultants wanting to excel in the medical device industry. It is not a sit-back-and-relax course, the pace is fast and the course is demanding. Even so, 95% of participants report that it is the best course they have taken.

Course programme

Day 1

  • Introduction to design control and key terms
  • Project process
  • The regulatory framework
  • Classifcation and product approval
  • Essential requirements, standards and guidelines
  • Standards in medical device product development
  • Introduction to project management
  • What is enough?
  • Medical device files

Day 2

  • The project process of the course
  • Selecting tools and techniques
  • Develop project charter
  • Identify stakeholders
  • General introduction
  • Collect requirements
  • Define design and development inputs
  • How to manage requirements
  • Define scope
  • Risk management and usability engineering

Day 3

  • Plan verification and validation
  • Create work breakdown structure
  • Create schedule
  • Develop human resource plan
  • Project risk management
  • Estimate cost and determine budget

Day 4

  • Develop project management plan
  • Design review
  • Direct and manage project execution
  • Control schedule/control costs
  • Control scope
  • Manage communications
  • Monitor and control risk
  • Document pitfalls
  • Design transfer
  • Design verification and validation
  • Design review
  • Close project or phase
  • Repetition

Are you interested in taking this Project Management classroom course?

Click on the button to request information for this course.

Frequently asked questions

Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
The instructor maintains a PMP certification from the Project Management Institute. For the design control elements of the course, there is no certification or accreditation, 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. Ensuring the instructor has the most up to date knowledge and information is the highest qualifications for teaching the course.
The maximum number is 15. Any more than 15 people inhibits the interactive elements.

Yes, you can have the course as an in-house course. Please use the contact form to request a proposal and we will get back to you right away.

Recommended minimum pre-requisites for this course are any or all of the following: experience with product development in a regulated industry, experience from working in project organisation, or with ISO 13485/21 CFR 820.
Yes, but only if you are present 75% or more of the course duration. You also have to be active on the course to be eligible for the certificate.
The course fee is at the top of this page. For more information, please request the course programme by filling out the form.
The date of the next course at the top of this page. For more information about the location and future courses, please request the course programme by filling out the form.


Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.