Latest / Medical Device made Easy Podcast
Why you should use Pre-Submission or Q-Sub with FDA?
We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll see that this may be your Superpower to accelerate your success with your FDA application. Let’s listen to Saad Attiyah who will explain what is Q-SUB.
Who is Saad Attiyah?
Experienced Regulatory Affairs and Quality Assurance professional with 20+…
The skinny
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