What is project management for product development of medical devices? And most importantly, why should you be working with project management in the medical device industry? 

In this article, you will find the basic principles and practices of project management with some important perspectives relating to medical devices. 

If you want to know more about project management for medical devices, take a look at the video below which is part of our online course on Project Management for product development of medical devices 

Why project management?

There are several reasons for why project management is crucial when developing medical devices.  

Implementing good project management in an organisation that supports the projects that are being worked on results in multiple benefits.  

Not only can it reduce the time to get the product to market, but it can also lower project costs which saves the organisation money, and create competitive products that comply with regulatory requirements.  

What is a medical device project?

There are three things that are normally associated with a project in general, and these are true for medical device projects as well.  

This includes a defined scope or result, a schedule or time constraint and lastly, a budget to stick to. These project dimensions are usually depicted in the shape of a triangle.  

The project management triangle

Different companies use various synonyms or names for these aspects, but they all ultimately come down to these three, regardless of the names. 

Therefore, a project generally has: 

  • a defined scope (result, quality, product) 
  • a schedule (time constraint) 
  • a budget (cost, resources) 

The people: who are involved in a project?

People that work on a project all have their roles and responsibilities. Three common roles of a project organisation are:  

  • the members of the steering group 
  • the project manager 
  • the team members 

The steering group is the group of people who own and provide the resources for the project. They also influence the requirements throughout and maintain the result after completion. 

The project manager is responsible for the timely execution of the project according to the schedule. 

Finally, the team members are the people who are doing the specific work during all of the stages of the project.  

Another important aspect of project management is the project plan. The project plan is there to ensure that everything is agreed upon and that every step and action is documented.  

The body of knowledge

There is one book that everyone who works in project management should read if they want to do their job properly. 

The Project Management Body of Knowledge, PMBOK for short, is a standardised comprehensive source of processes, tools, and terminology for project management.  

Project management professional certification

Because it is the most comprehensive and up-to-date reference book on project management that can be found, you can even be certified as a project manager based on it. That certification is referred to as PMP, or Project Management Professional. 


Speaking of the PMBOK, it defines a project as a 

‘’Temporary endeavor undertaken to create a unique product, service, or result.’’ 

To sum it all up, project management can be defined as the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements. Ultimately, the job of a good project manager is to bring the product to the market by any ethical and legal means they can. 

Read more about project management and other topics we offer our courses on here 

Would you like to know more about Project Management?

Take a look at our online Project Management for Product Development of Medical Devices 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. 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

We recommend that you take the Introduction to Design Control for Medical Devices online course prior to taking this course.

Peter Sebelius instructor

Peter Sebelius

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.