RA/QA guest lectures – week 4 – Software as a medical device and Qualification & Validation

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

Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.

The interesting day started off with the guest lecture of project manager Pieter: Software as a medical device. The aim of his lecture was to give the students a brief overview of how to validate software as a medical device. For Pieter this training was a nice change of pace as he went to our QbD HQ in Wilrijk to give the lecture remotely. As such he was able to leave the house for once as working from home is the new standard at QbD due to covid-19.
During the lecture they touched subjects as regulation, applicable standards and software validation so afterward the students knew what actions are expected from a software as a medical device company to bring their new product to the market.

After a short break, it was time for the lecture of validation expert Bart. He introduced the students in to the interesting world of validation and qualification. After an introduction of why it’s necessary to perform validation in the pharmaceutical world Bart and the students explored the requirements set out in Annex 15. By using 2 real life examples to explain these requirements it made everything more clearly. The examples he has chosen were an easy thermometer and a complex depyrogenation tunnel. Finally he gave an introduction in method, cleaning and process validation.

Next week, the students will get one more guest lecture on FDA and medical devices

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