two-day course: december 1 and 2 2025
In this two-day course, we work with a personalized approach. That includes an intake interview to determine your specific MDR needs. During the course a match will be made with relevant (medical) experts and/or end-users who can provide input for the risk analysis and clinical benefit assessment.
For whom, by whom?
- (Start-up) entrepreneurs or teams of researchers developing medical devices.
- Experts from the University of Twente in the field of Medical Device Regulation
- Medical specialists relevant to your specific product.
Course Overview and Learning Objectives
• Determination of intended use, classification and CE route
• Application of relevant ISOs such as 14385, 14971
• Risk analysis with a multidisciplinary team
• Preparing tests to demonstrate clinical benefit
What will you gain?
• Detailed insight of the MDR (Medical Device Regulation)
• Direct contact with the intended users (medical specialists)
• Knowledge needed to effectivly conduct risk analysis and clinical investigation for your product.
• Tools to proficiently direct an MDR consultant
Registration and information
I want to sign up for the MDR fall course Sign in MDR 2025
- Next start date, December 1 and 2 2025, 2 consecutive days. (dates in consultation)
- For more information send a mail to: Techmedacademy@utwente.nl
- The Courseprice is € 3.000,00 per company. Three employees per company can attend the course. Maximum participants 3 companies.
- The course will be held on the campus of the University of Twente.
- Our cancellation policy: Cancellation policy
TechMed Academy / Technohal (nr. 18)
Hallenweg 5,7522 NH ENSCHEDE Netherlands
E-Mail: Techmedacademy@utwente.nl
Phonenumber: 053-4898401
Route: https://www.utwente.nl/nl/techmed/over/contact/