DESIGN CONTROL FOR MEDICAL DEVICES COURSECourse Category - PUBLIC COURSE / IN-HOUSE 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.
All the contents of this course is included in the Project Management for Product Development of Medical Devices course.
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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.
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.
- 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
Are you interested in taking this Design Control classroom course?
Click on the button to request information for this course.
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?
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.
What are the pre-requisites for this course?
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.
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.
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.
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.