#370: Meet a Guru: Jamie Bihary

#370: Meet a Guru: Jamie Bihary

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#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead

The FDA is actively shaping the regulatory landscape for Artificial Intelligence (AI) and Machine Learning (ML) in real time. As the agency expands its internal expertise through the Digital Health Center of Excellence, FDA reviewers are becoming highly sophisticated. The era of ...  Show more

#459: The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires

The MedTech industry widely misread the FDA's recent warning letter to Purolea Cosmetics Lab as a direct crackdown on Artificial Intelligence (AI). Host Etienne Nichols challenges this narrative, explaining that viewing the event strictly through an AI lens causes medical device ...  Show more

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