RA/QA guest lectures – week 5 – FDA & Medical Devices

(This blog is part of a series. Want to read the previous part? Check it out here)

On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices. She explained the students what the FDA is, the definition and classification of medical devices in the US, how you can bring a medical device to the US market, and some things you have to do to keep your product on the market. Lastly, the differences with the European market were discussed.

Since the social distancing rules are still applicable, this guest lecture was held online. For Maaike it felt strange to talk to a computer for a few hours, but by including some online assignments and a quiz she was able to interact with the students.

Unfortunately this was the last lecture of the QbD RA/QA guest lectures series for the University of Liège. It was a pleasure for QbD and all our trainers to introduce the biomedical engineers of the future into the world of life sciences.

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