FDA regulation
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Episode 37 – Usability & Human Factor with Sharon Ayd
Let's not talk about theory but really about experience when we are looking for Usability tests and Human Factors. Sharon Ayd will share with us a project where she was able to use these notions to succeed.
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Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator.
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Episode 30 – Promotional Compliance with Darshan Kulkarni
The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products.
