DESIGN CONTROL FOR MEDICAL DEVICES COURSE
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.
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.
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 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
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.
About the instructor
Peter Sebelius (PMP) 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 too having developed, amongst other things, a mechanical chest compression 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.
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.
- 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
- 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
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
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
PUBLIC COURSE / IN-HOUSE COURSE
7 October, 2020. Hørsholm Denmark
Frequently Asked Questions
Do I get a copy of the course presentation?
Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
Are you accredited or certified to give this training?
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.
Can we have the course as an in-house course?
What are the pre-requisites for this course?