RA/QA guest lectures – week 3 – Roadmap to CE-marking
(This blog is part of a series. Want to read the first part? Check it out here)
After the Easter holidays, QbD resumed its guest lectures for the biomedical engineering students at the University of Liège. This week, our experienced consultants Jeroen Verhoeven and Steven Vinckx introduced them to the CE-marking roadmap. All this from a ‘social distance’ of course – which is about a hundred kilometers in this case…
Steven and Jeroen explained the basic principles of the MDR (medical device regulations). After introducing them to innovation in the med tech industry, students learned about the definition of a medical device, post market surveillance (PMS), EUDAMED, notified bodies and design and development. During an interactive workshop, they classified different devices. In the end, they applied the learnings of the course by defining their own roadmap to CE-marking for their specific group projects.
Next week, the students will get two more guest lectures, one on Software as a Medical Device and one on Process Validation.