This is a 2-day course focused on how to develop new medical devices and maintain them in organisations where design control requirements apply. The course covers both European and US requirements.

Promotional video for the online course design control for medical devices


Course length
4 days
Course fee (per person)
€ 1190
90-day early bird special
€ 1071

Course description

The course addresses documentation requirements and provides tools on how to work successfully and efficiently with design control. It references the most commonly used standards such as ISO 14971 on risk management and IEC 62366 on usability engineering.

We recommend this course for professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.

All the contents of this course is included in the Project Management for Product Development of Medical Devices 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

Knowing where you are in the process is key to making the right next moves. Many of our students come to the course saying that they looked for the perfect overview, and got it.
Design control can be made incredible abstract if the instructor focuses too much on the intangible requirements instead of how to actually do the work. The course is very practical in its approach and covers both how to find and interpret requirements as well as how to implement with a lean and pragmatic approach, potentially saving you tons of time.
We pride ourselves on making a topic that could be considered somewhat “dry” and “boring” interesting and even fun. The course has a high pace with a high level of interactivity.

Course programme

Day 1

  • Introduction to design control and key terms
  • Project process
  • The medical device files
  • The regulatory framework
  • Classifcation and product approval
  • Essential requirements, standards and guidelines
  • Using standards in medical device product development
  • Design and development inputs and traceability
  • How to manage requirements
  • Risk management and ISO 14971

Day 2

  • IEC 62366-1
  • Design planning
  • Design review
  • Design phase and design output
  • Design transfer
  • Design verification and validation
  • The product approval process
  • What is enough?
  • Design release
  • Change control
  • Documentation pitfalls

Are you interested in taking this Design Control 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.
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.
The maximum number is 15. With more people on the course, you loose the interactivity and people won’t dare to ask questions.

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.

There are no pre-requisites but it is helpful to have experience from product development in medical device industry or any other regulated industry or experience from the medical device industry in general.
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.