Since 2023, I have been part of the TechMed Research Support team as an advisor on medtech regulations. My goal is to help researchers at the University of Twente navigate the regulatory landscape and understand how medical device regulations impact their work. I draw on my experience in medical device research across both industry (Vitatron, Medtronic, Qserve) and academia (UMC Utrecht, AMC, Radboud UMC).
The production and sale of medical devices are regulated by laws such as the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR). Additionally, your research on medical technology may also fall under these regulations or under the Medical Research Involving Human Subjects Act (WMO). Your choice of a research question and how you use technology in your study can determine which regulations apply and the amount of paperwork you'll have to deal with. Planning your research carefully can help you stay flexible, lower risks, and make it easier to move toward using your work in medical practice.
Feel free to reach out if you have questions about:
* The regulatory requirements for your clinical study with a research prototype.
* How to prepare and document your technology for a smooth transition to a spin-off.
* Practical R&D decisions or coaching a UT student during an internship.
I am always open to discussing the practical and regulatory aspects of medtech research.
Organisations
Courses academic year 2024/2025
Courses in the current academic year are added at the moment they are finalised in the Osiris system. Therefore it is possible that the list is not yet complete for the whole academic year.
Address
University of Twente
Technohal (building no. 18), room 2106
Hallenweg 5
7522 NH Enschede
Netherlands
University of Twente
Technohal 2106
P.O. Box 217
7500 AE Enschede
Netherlands
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