Design control for medical devices

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.





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 of this course is included in our Project Management for product development of medical devices course


Benefits for you

Overview of the process

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.

Know why and how to work with design control

Design control can be made incredible abstract if the instructor focuses too much on abstract 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

Fun and interactive

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.


Really informative and applicable, very well organised and implemented. A lot of lessons learned for me, that I will definitely share with colleagues in my next assignment.
The practical exercises were useful and helped to enrich the discussions in a very positive way.

I highly appreciated Peter’s professional knowledge and his pedagogic skills to keep the group engaged and alert. The two days whizzed by and I learnt a lot for my daily work.

This was the best course I have been on in a long time. The presenter had a good teaching style, a lot of energy and enthusiasm. I will definitely recommend this course to my colleagues.


Course programme

Day 1

  • Introduction
  • 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 ISO14971

Day 2

  • Usability engineering
  • 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



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.


Frequently asked Questions

Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.

For the course price, you will get the course, course material, templates , coffee and snacks throughout the day and snacks. For courses held in Hörsholm, also breakfast is included.

There is no certification or accreditation for design control, however the instructor has documented training in the field since many years and continuously participate in authoring standards such as the ISO 13485 and ISO 14971, making sure the instructor is up to date and has the highest qualifications 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.

Sure, I will be happy to send a proposal for a company internal version of this course to you. Use the contact form to request a proposal.

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.

Please request the course programme by filling out the form below to get the programme including pricing and early bird discounts when applicable.

Please request the course programme by submitting the form below. Dates and venues are found for each course in the programme. The programme also contains more detailed information on the course than this page.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800.